{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-05", "results": { "skip": 0, "limit": 1, "total": 3810 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "1119779-2020-00087", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200508", "manufacturer_address_2": "", "pma_pmn_number": "NA", "date_of_event": "20200425", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "FOREIGN", "OTHER", "USER FACILITY" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "UK", "manufacturer_contact_area_code": "", "date_added": "20200508", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "500916", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200508", "brand_name": "PANEL PHOENIX NMIC 417", "generic_name": "PHOENIX PANEL", "manufacturer_d_name": "BECTON, DICKINSON & CO.", "manufacturer_d_address_1": "7 LOVETON CIRCLE", "manufacturer_d_address_2": "", "manufacturer_d_city": "SPARKS", "manufacturer_d_state": "MD", "manufacturer_d_zip_code": "21152", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "21152", "device_operator": "0", "expiration_date_of_device": "20201231", "model_number": "", "catalog_number": "449001", "lot_number": "9352950", "other_id_number": "", "device_availability": "No", "device_report_product_code": "LON", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "1119779" ], "fei_number": [ "1119779" ], "device_name": "System, Test, Automated, Antimicrobial Susceptibility, Short Incubation", "medical_specialty_description": "Microbiology", "regulation_number": "866.1645", "device_class": "2" } } ], "product_problems": [ "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/29/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250725", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200508", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200526", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10040328", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200429", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "317168405", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H.6. INVESTIGATION SUMMARY THIS COMPLAINT IS FOR FALSE RESISTANT GENTAMICIN RESULTS WITH PROTEUS MIRABILIS WHEN USING PHOENIX PANEL NMIC 417 (449001) BATCH 9342950. THE CUSTOMER PROVIDED LAB REPORT RESULTS FOR INVESTIGATION; HOWEVER, NO PRODUCT RETURNS OR ISOLATES WERE PROVIDED. FOUR RETENTION PANELS FROM THE COMPLAINT LOT WERE USED TO TEST QC ISOLATES ATCC 27853 (EXPECTED MIC =0.5-1) AND ATCC 25922 (EXPECTED MIC =0.5-2) (TWO PANELS PER ISOLATE). BOTH PANELS USED TO TEST THE ATCC 25922 STRAIN YIELDED A GENTAMICIN MIC OF =1, SENSITIVE. BOTH PANELS USED TO TEST THE ATCC 27853 STRAIN YIELDED A GENTAMICIN MIC OF 2, SENSITIVE. FOUR IN-HOUSE ISOLATES ALSO TESTED WITH RETENTION PANELS OF THE COMPLAINT BATCH AND ALL YIELDED SENSITIVE RESULTS AS EXPECTED. THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED FOR THIS DEFECT. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THIS DEFECT AND TAKE ACTION AS REQUIRED." }, { "mdr_text_key": "317168406", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ NMIC-417 PANEL AN INCREASED AMOUNT OF HIGH MIC RESULTS FOR PROTEUS MIRABILIS/GENTAMICIN COMBINATION WERE REPORTED. THIS ISSUE RESULTED IN RESISTANCE RESULTS BEING REPORTED TO THE CLINICIAN. TWELVE SAMPLES WERE IDENTIFIED PRIOR TO REPORTING, BUT THERE IS NO DATA ON PRIOR SAMPLES. IT IS UNKNOWN HOW MAY ERRONEOUS RESULTS WERE REPORTED TO CLINICIANS. RESISTANCE TO GENTAMICIN IS RARE, BUT NOT UNUSUAL SO A CONFIRMATORY TEST IS NOT STANDARD PROCEDURE." }, { "mdr_text_key": "191392609", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED." }, { "mdr_text_key": "191392610", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ NMIC-417 PANEL AN INCREASED AMOUNT OF HIGH MIC RESULTS FOR PROTEUS MIRABILIS/GENTAMICIN COMBINATION WERE REPORTED. THIS ISSUE RESULTED IN RESISTANCE RESULTS BEING REPORTED TO THE CLINICIAN. TWELVE SAMPLES WERE IDENTIFIED PRIOR TO REPORTING, BUT THERE IS NO DATA ON PRIOR SAMPLES. IT IS UNKNOWN HOW MAY ERRONEOUS RESULTS WERE REPORTED TO CLINICIANS. RESISTANCE TO GENTAMICIN IS RARE, BUT NOT UNUSUAL SO A CONFIRMATORY TEST IS NOT STANDARD PROCEDURE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/27/2020" } ] }