BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 17738557 · Received September 13, 2023

    Report

    Report Number
    3005094123-2023-00240
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    August 25, 2023
    Report Date
    September 26, 2023
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    PMA / PMN Number
    K170317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY I TOTAL BHCG, LIST 07P51-30, ABBOTT IRELAND DIAGNOSTICS DIVISTION, LONGFORD, IRELAND TO THE ALINITY I PROCESSING MODULE, LIST 03R65-01, ABBOTT LABORATORIES, IRVING, TEXAS, USA. MDR NUMBER 3016438761-2023-00514-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY INCREASED ALINITY I TOTAL HCG RESULTS ON ONE PATIENT THAT IS UNLIKELY PREGNANT DUE TO HORMONE PROFILE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) PROCESSED ON (B)(6) 2023 INITIAL RESULT = 76. THERE IS NO RETEST RESULT AVAILABLE. SAMPLE WAS A SHORT SAMPLE THAT WAS HEMOLYZED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY INCREASED ALINITY I TOTAL -HCG RESULTS ON ONE PATIENT THAT IS UNLIKELY PREGNANT DUE TO HORMONE PROFILE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) PROCESSED ON 25AUG2023 INITIAL RESULT = 76 THERE IS NO RETEST RESULT AVAILABLE SAMPLE WAS A SHORT SAMPLE THAT WAS HEMOLYZED NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1589724 ALINITY I TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 45628UD00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY I PROCESSING MODU, 03R65-01, AI21710| ALNTY I PROCESSING MODU, 03R65-01, AI21710