BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1161201 · Received September 15, 2008

    Report

    Report Number
    1823260-2008-06895
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    July 15, 2008
    Report Date
    September 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED SHE AWOKE WITH HYPOGLYCEMIC SYMPTOMS AND OBTAINED A RESULT OF 180 MG/DL ON THE ADVANTAGE SYSTEM. REPORTER STATED SHE WAS NOT ABLE TO TREAT HERSELF, SO HER CAREGIVER GAVE HER A HALF CUP OF COFFEE WITH SUGAR IN IT. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT. REPORTER DID NOT HAVE INFO ABOUT THE STRIPS USED, AND SO NO PRODUCT WILL BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention NOVOLIN 70/30 - 1 YEAR