BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 854469 · Received May 22, 2007

    Report

    Report Number
    1823260-2007-04374
    Event Type
    Injury
    Date Received
    May 22, 2007
    Date of Event
    April 25, 2007
    Report Date
    May 22, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED CUSTOMER WAS UNCONSCIOUS AND BLOOD GLUCOSE RESULT WAS 118 MG/DL ON THE CUSTOMER'S ADVANTAGE SYSTEM. REPORTER STATED THE PARAMEDICS ARRIVED AND WITHIN 5-10 MINUTES LATER THEIR GLUCOSE MEASUREMENT FOR THE CUSTOMER WAS 48 MG/DL. REPORTER INDICATED CUSTOMER WAS TREATED WITH A "GLUCOSE WATER INJECTION." REPORTER STATED INSULIN WAS LAST DELIVERED ONE HOUR BEFORE THE EVENT BASED ON A VALUE OF > 200 MG/DL AND A NORMAL BLOOD GLUCOSE VALUE FOR THE CUSTOMER IS REPORTED TO BE 100-147 MG/DL. IT WAS STATED THE TEST STRIPS BEING USED AT THE TIME OF THE TESTING WERE EXPIRED. NO OTHER ACTIONS OR TREATMENT WAS REPORTED. 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 COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 548465

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R TERAZOSIN 1 YR - 1MG ONCE DAILY| GLARGINE INSULIN 4YRS-30UN&20UN EACH DOSE ONCE DAI| ASUZONZIN 1 YR - 10MG ONCE DAILY| HYDROCHLOROTHIAZIDE 1 YR - 25MG ONCE DAILY| BENAZEPRIL 1 YR - 40MG ONCE DAILY| ZOCOR 1 YR - 80MG ONCE DAILY| NIFEDIPINE 1 MO - 60MG TWICE DAILY| ASPART INSULIN 4 YRS - 20UN WITH EVERY MEAL| MEFORMIN 1 MO - 500MG TWICE DAILY| METOPROLOL TARTRATE 1 YR - 50MG ONCE DAILY