BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT B-HCG CARTRIDGE

    MDR report key: 19861948 · Received July 30, 2024

    Report

    Report Number
    2245578-2024-00154
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    June 26, 2024
    Report Date
    September 4, 2024
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    DHA
    PMA / PMN Number
    K133002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 27-AUG-2024. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AN (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN IDENTIFIED FOR TOTAL B-HCG CARTRIDGE LOT F24084C.

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT B-HCG CARTRIDGES THAT YIELDED POSITIVE RESULTS ON 47 YEAR FEMALE PATIENT SCREENED FOR MALIGNANT NEOPLASM COLON. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULTS SAMPLE: I-STAT (B)(6) 2024 10:12 10:12 116.0 IU/L WB THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY. I-STAT POSITIVE CUT-OFF VALUES: B-HCG < 5.0 IU/L NEGATIVE 5.0 < SS-HCG < 25.0 IU/L INDETERMINATE B-HCG >25.0 IU/L POSITIVE INTENDED USE: THE I-STAT® TOTAL BETA-HUMAN CHORIONIC GONADOTROPIN (B-HCG) TEST IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUANTITATIVE AND QUALITATIVE DETERMINATION OF B-HCG IN VENOUS WHOLE BLOOD OR PLASMA SAMPLES USING THE I-STAT 1 ANALYZER SYSTEMS. THE TEST IS INTENDED TO BE USED AS AN AID IN THE EARLY DETECTION OF PREGNANCY AND IS FOR PRESCRIPTION USE ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200829 I-STAT B-HCG CARTRIDGE B-HCG CARTRIDGE DHA ABBOTT POINT OF CARE NA F24084C

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female