BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT B-HCG CARTRIDGE

    MDR report key: 19023292 · Received April 2, 2024

    Report

    Report Number
    2245578-2024-00071
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    March 25, 2024
    Report Date
    April 28, 2024
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    DHA
    UDI-DI
    10054749001009
    PMA / PMN Number
    K133002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 29-APR-2024. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS RELEASE CRITERIA. 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 F23311A.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ON 27-MAR-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT B-HCG CARTRIDGES THAT YIELDED A POSITIVE RESULT ON A 13 YEAR OLD FEMALE PATIENT WITH OSTEOGENESIS IMPERFECTA. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE TESTED RESULTS SAMPLE I-STAT (B)(6) 2024 09:26 30.3 1 I-STAT (B)(6) 2024 09:50 23.7 2 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
    1269925 I-STAT B-HCG CARTRIDGE B-HCG CARTRIDGE DHA ABBOTT POINT OF CARE NA F23311A 10054749001009

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female