BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    PREMIER HB9210 HBA1C CONTROL KIT

    MDR report key: 12819907 · Received November 16, 2021

    Report

    Report Number
    1931251-2021-00001
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Report Date
    October 28, 2021
    Manufacturer
    PRIMUS CORPORATION
    Product Code
    LCP
    UDI-DI
    05391516748087
    PMA / PMN Number
    K112015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    HBA1C CONTROL I OF LOT 12160 OBSERVED WITH VALUES ABOVE THE ACCEPTABLE TARGET RANGE. VENDOR IDENTIFIED AN UNCOMMONLY HIGH GLUCOSE LEVEL IN THE CONTROL MATERIAL WHICH GLYCATES OVER TIME CREATED FALSE HIGH VALUES. PRODUCT LOT HAD BEEN PLACED ON SHIPPING HOLD NEAR THE SAME TIME AS THE COMPLAINT. NO KNOWN REPORTING TO MEDICAL STAFF OR PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716303 PREMIER HB9210 HBA1C CONTROL KIT HBA1C ASSAY LCP PRIMUS CORPORATION 01-04-0020 12160 05391516748087

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other