BEUDAMED
    FDA Adverse Event Summary report: N

    ACT-LR CUVETTES HEMOCHRON ELITE LOW RANGE ACT

    MDR report key: 12377191 · Received August 26, 2021

    Report

    Report Number
    MW5103528
    Date Received
    August 26, 2021
    Date of Event
    August 20, 2021
    Report Date
    August 24, 2021
    Manufacturer
    ACCRIVA DIAGNOSTICS, INC.
    Product Code
    JPA
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUVETTE FAILED QUALITY CONTROL 8 MONTHS BEFORE EXPIRATION DATE. DIFFERENT LOT NUMBER, SAME EXPIRATION DATE, SAME STORAGE CONDITIONS PASSED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272427 ACT-LR CUVETTES HEMOCHRON ELITE LOW RANGE ACT SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES JPA ACCRIVA DIAGNOSTICS, INC. A1JLR011

    Patients

    Seq Age Sex Outcome Treatment
    1