BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1760960 · Received July 17, 2007

    Report

    Report Number
    1823260-2007-06181
    Event Type
    Malfunction
    Date Received
    July 17, 2007
    Date of Event
    June 29, 2007
    Report Date
    July 17, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED CUSTOMER HAD BEEN RECEIVING HIGHER READING OF 300-400 MG/DL FOR 2 DAYS AND WENT TO THE DOCTOR AS A RESULT TO HAVE GLUCOSE TESTED. REPORTER STATED THE CUSTOMER'S ADVANTAGE SYSTEM READ 352 MG/DL COMPARED TO THE DOCTOR'S MEASUREMENT OF 135 MG/DL IN ADDITION TO THE SECOND COMPARISON OF 392 MG/DL FROM CUSTOMER'S SYSTEM VERSUS 130 MG/DL ON THE DOCTOR'S SYSTEM. NO EXACT TIMEFRAME BETWEEN TESTING WAS PROVIDED OTHER THAN THE REFERENCE TO BACK TO BACK. REPORTER INDICATED THE CUSTOMER WAS NOT EXPERIENCING ANY HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF THE TESTING. NO REPORT OF ANY OTHER ACTIONS TAKEN OR TREATMENT RECEIVED. 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 LFR ROCHE DIAGNOSTICS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR CALCIUM| METFORMIN - 2MOS - 500MG TWICE DAILY| BLOOD PRESSURE MEDICATION