BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1243013 · Received November 21, 2008

    Report

    Report Number
    1823260-2008-08675
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    November 12, 2008
    Report Date
    November 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    RPTR ALLEGED THE CUSTOMER WAS DELIRIOUS AND SCREAMING, SO SHE TESTED HIM ON THE ADVANTAGE SYS AND OBTAINED A RESULT OF 149 MG/DL. RPTR STATED SHE UNSUCCESSFULLY TRIED TREATING HIM WITH SODA AND CALLED THE PARAMEDICS. RPTR STATED THE PARAMEDICS ARRIVED AND OBTAINED RESULTS OF 35 MG/DL AND 32 MG/DL ON THEIR SYS WITHIN 10 MINS OF THE 149 MG/DL RESULT ON THE ADVANTAGE SYS. RPTR STATED THE PARAMEDICS GAVE THE CUSTOMER GLUCOSE IN AN IV AND THEN SHE GAVE HIM JUICE. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT REC'D. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PROD 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 LFR ROCHE DIAGNOSTICS 550804

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention LANTUS - 55 UNITS NIGHTLY| HUMALONG - SLIDING SCALE