BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1201477 · Received October 17, 2008

    Report

    Report Number
    1823260-2008-07719
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A 177 MG/DL ON THE ACTIVE S SYSTEM WHILE USING EXPIRED STRIPS AND FEELING HYPOGLYCEMIC SYMPTOMS. REPORTER STATED HE OBTAINED ANOTHER READING OF 203 MG/DL AND HE WENT TO THE ER BECAUSE HE DID NOT BELIEVE THE RESULT. REPORTER STATED THE ER OBTAINED A RESULT OF 91 MG/DL ON THEIR SYSTEM 2 HOURS AFTER THE 177 MG/DL RESULT WAS OBTAINED. REPORTER STATED THEY TREATED HIM WITH JELLO, JUICE, AND IV. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT REC'D. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 22901732

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention METOPROLOL - 1 YEAR - 0.5MG DAILY| HUMULIN 70/30 - 2 YEARS - 120 UNITS DAILY| SIMVASTATIN - 1 YEAR| LISINOPRIL - 6 MONTHS| GLIPIZIDE - 6 MONTHS| FUROSEMIDE - 6 MONTHS - 40MG TWICE DAILY| METFORMIN - 1 YEAR - 20MG TWICE DAILY| KLOR-CON - 6 MONTHS - 20MG DAILY