BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION PRIME GLUCOSE TEST STRIPS

    MDR report key: 10419674 · Received August 17, 2020

    Report

    Report Number
    MW5096097
    Event Type
    Malfunction
    Date Received
    August 17, 2020
    Date of Event
    August 13, 2020
    Report Date
    August 13, 2020
    Manufacturer
    WAL-MART STORES, INC.
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PURCHASED BOTTLE OF 50 RELION PRIME BLOOD GLUCOSE TEST STRIPS AT (B)(6). ON THE OUTER BOX: LOT: 060820D, EXP: 2022-02-10. ON THE BOTTLE: LOT 100918A, EXP: 2020-05-08. ARE THEY 3 MONTHS PAST EXPIRATION? FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877925 RELION PRIME GLUCOSE TEST STRIPS GLUCOSE OXIDASE, GLUCOSE CGA WAL-MART STORES, INC. NDC 08317-7000-50 060820D

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR