BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1023399 · Received April 2, 2008

    Report

    Report Number
    1823260-2008-02927
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    March 25, 2006
    Report Date
    April 2, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    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

    CUSTOMER'S HUSBAND REPORTS HE COULD NOT TEST CUSTOMER BECAUSE HE COULD NOT OBTAIN A GOOD BLOOD DROP WHILE USING THE COMPACT PLUS SYSTEM. HUSBAND REPORTS CUSTOMER WAS DAZED AND STARING INTO SPACE; HE STATES HE TRIED TO TREAT CUSTOMER WITH CHOCOLATE, BUT SHE COULD NOT SWALLOW IT. HUSBAND REPORTS HE CALLED 911 AND EMTS CAME AND CHECKED CUSTOMER'S BLOOD GLUCOSE; RESULT RECEIVED AND TREATMENT PROVIDED WAS UNK. HUSBAND STATES EMTS TOOK CUSTOMER TO THE HOSPITAL, THEY TESTED HER AND HE BELIEVED THEY GAVE CUSTOMER SOME INSULIN; BLOOD GLUCOSE RESULT WAS UNK. HUSBAND REPORTS CUSTOMER WAS IN THE HOSPITAL FOR 2 DAYS. NO CONTROL INFO WAS PROVIDED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention NOVOLOG 50 UNITS BEFORE EACH - MEAL 1YR| LANTUS 50 UNITS PM - 1YR