BEUDAMED
    FDA Adverse Event Summary report: N

    CHEMSTRIP BG

    MDR report key: 11071 · Received January 26, 1994

    Report

    Report Number
    MW1000493
    Date Received
    January 26, 1994
    Report Date
    January 25, 1994
    Manufacturer
    DIAGNOSTICS DIV. BOEHRINGER MANNHEIM
    Product Code
    CFR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE OUTSIDE BOX HAD A PRODUCT NUMBER OF 502-50, (LOT 252374, EXPIRATION DATE 4/1/95). THIS WAS THE PRODUCT ORDERED. THE INSIDE CONTAINER HAD A PRODUCT NUMBER OF 503-50, (LOT 252274, EXPIRATION DATE 5/1/93). THE DISCREPANCY WAS DISCOVERED BECAUSE THE 503-50 PRODUCT WOULD NOT WORK IN THE PT'S BLOOD GLUCOSE MACHINE. THE REPORTER IS CONCERNED THAT HAD THE PT NOT BEEN IN THE HOSP, THE PROBLEM WOULD NOT HAVE BEEN PICKED UP QUICKLY. THE REPORTER STATED THAT THE BOX HAD BEEN SEALED WITH THE MFR'S USUAL CLEAR TABS ON BOTH ENDS OF THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEMSTRIP BG CFR DIAGNOSTICS DIV. BOEHRINGER MANNHEIM 252374, 252274

    Patients

    Seq Age Sex Outcome Treatment
    1 *