{ "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": "2026-07-07", "results": { "skip": 0, "limit": 1, "total": 12224510 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "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": "Malfunction", "report_number": "2919069-2008-00378", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20080220", "manufacturer_address_2": "", "pma_pmn_number": "K051215", "date_of_event": "20071210", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Consumer", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20091228", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080220", "brand_name": "CELL-DYN SAPPHIRE ANALYZER", "generic_name": "AUTOMATED HEMATOLOGY ANALYZER", "manufacturer_d_name": "ABBOTT DIAGNOSTICS DIVISION/CELLDYN", "manufacturer_d_address_1": "5440 PATRICK HENRY DR.", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95054", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95054", "device_operator": "OTHER", "model_number": "NA", "catalog_number": "8H00-01", "lot_number": "NA", "other_id_number": "NA", "device_availability": "Yes", "device_report_product_code": "GKZ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "2919069" ], "fei_number": [ "2919069" ], "device_name": "Counter, Differential Cell", "medical_specialty_description": "Hematology", "regulation_number": "864.5220", "device_class": "2" } } ], "product_problems": [ "Syringe, defective", "Device Displays Incorrect Message" ], "reporter_state_code": "KY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250730", "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": "20080220", "sequence_number_treatment": [ "CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE", " LIST #08H49-02" ], "sequence_number_outcome": [ "" ], "patient_age": "NI", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20080122", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1000002", "removal_correction_number": "2919069-8/6/07-004-C", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Relabeling", "Recall", "Replace" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "788210", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE CUSTOMER CONTACTED ABBOTT REGARDING INTERMITTENT HEMOGLOBIN SYRINGE \"FAIL TO HOME\" ERROR MESSAGES GENERATED FROM THE CELL-DYN SAPPHIRE HEMATOLOGY ANALYZER. THE CUSTOMER STATES THE SYRINGE WAS CLEANED AND RESEATED, BUT ERROR RECURRED WITHIN AN HOUR OF SYRINGE CLEANING. THE CUSTOMER WAS INSTRUCTED TO POWER DOWN THE ANALYZER, BUT FOLLOWING RE-BOOT OF THE ANALYZER, THE ANALYZER PRIMED, AND THE SYRINGE ERROR RECURRED DURING QUALITY CONTROL SAMPLING. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE DISPATCHED SERVICE TO THE CUSTOMER FACILITY. PRIOR TO SERVICE ARRIVING AT THE CUSTOMER FACILITY, THE CUSTOMER INSTALLED A NEW SYRINGE AND THE ISSUE WAS RESOLVED. THE CUSTOMER REPORTED THERE WAS NO IMPACT TO PT MANAGEMENT." }, { "mdr_text_key": "1255386", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "FORM 3500 MUST BE SUBMITTED IF A SECONDARY MALIGNANT FINDING OCCURRED. IN 2008, MAMMOGRAM AND CORE BIOPSY REVEALED MICROCALCIFICATIONS OF THE LEFT BREAST - ORIGINAL DIAGNOSIS ON RIGHT SIDE - AND A STEREOTACTIC CORE SHOWED DCIS." }, { "mdr_text_key": "7934126", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE." }, { "mdr_text_key": "8322422", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE, LIST # 8H49-02 THIS FOLLOW UP MDR FOR REMEDIAL CORRECTION 2919069-8/6/07-004-C IS SUBMITTED LATE. THE CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE, LIST NUMBER 8H49-02, WAS MANUFACTURED ON (B)(6) 2007 AND WAS IDENTIFIED BY THE VENDOR TO HAVE BEEN MANUFACTURED WITH INSUFFICIENT OR INCONSISTENT AMOUNT OF SILICONE LUBRICANT APPLIED TO THE TIP OF THE SYRINGE PLUNGER. THE AFFECTED SYRINGES WITH A PACKAGE DATE OF (B)(6) 2007, CAUSED THE CELL-DYN SAPPHIRE ANALYZER TO GENERATE AN ERROR MESSAGE UPON INSTALLATION OF THE SYRINGE OR SHORTLY THEREAFTER. THE CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE WAS DISTRIBUTED FOR THE CELL-DYN SAPPHIRE ANALYZER ONLY AND DID NOT IMPACT OTHER CELL-DYN ANALYZERS. THE ISSUE WAS RESOLVED WHEN A NEW CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE, LIST 8H49-04, WAS MANUFACTURED BY A NEW VENDOR AND RELEASED FOR DISTRIBUTION ON (B)(6) 2009." } ], "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": "12/28/2009" } ] }