BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1020031 · Received March 27, 2008

    Report

    Report Number
    1823260-2008-02810
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 14, 2007
    Report Date
    March 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED, METER RESULTS OF 80 MG/DL ON THE ACTIVE SYSTEM. REPORTED METER RESULTS OF 30 MG/DL OR 40 MG/DL WITHIN 10 MINUTES ON AN EMT'S METER. RE-TESTED WITHIN 10 MINUTES ON ACTIVE SYSTEM, RESULTS WERE 70 MG/DL OR 80 MG/DL. EMT TREATED CUSTOMER WITH GLUCOSE IV. A REQUEST WAS MADE FOR THE RETURN OF THE DEVICE, HOWEVER, CUSTOMER NO LONGER HAS THE STRIPS; A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention LANTUS 8 UNITS AS NEEDED - 1 YEAR| AMARYL 4 MG/DAY - 2 YEARS| AVANDIA 4 MG/DAY - 2 YEARS| GLUCOPHAGE 100 MG/2/DAY - 2 YEARS| ZESTRIL 10 MG/DAY - 1 YEAR