BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHECK FASTCLIX LANCETS 102'S 30G

    MDR report key: 20344379 · Received September 30, 2024

    Report

    Report Number
    MW5160334
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 21, 2024
    Report Date
    September 21, 2024
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    QRL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ACCU-CHECK FASTCLIX LANCETS NOT FITTING PROPERLY INTO FASTCLIX DEVICE. LANCE UNABLE TO DRAW BLOOD NO MATTER THE SETTING. PATIENT FAMILIAR WITH USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870810 ACCU-CHECK FASTCLIX LANCETS 102'S 30G MULTIPLE USE BLOOD LANCET FOR SINGLE PATIENT USE ONLY QRL ROCHE DIABETES CARE, INC. WPL130A

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female