BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1760939 · Received July 17, 2007

    Report

    Report Number
    1823260-2007-06195
    Event Type
    Malfunction
    Date Received
    July 17, 2007
    Date of Event
    June 13, 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
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED OBTAINING BACK TO BACK RESULTS OF 179 MG/DL AND 88 MG/DL ON THE ADVANTAGE SYSTEM. CUSTOMER ALSO REPORTED PERFORMING AN ADDITIONAL SET OF BACK TO BACK TESTS ON THE ADVANTAGE SYSTEM WITH RESULTS OF 341 MG/DL AND 116 MG/DL. NO QUALITY CONTROLS WERE RUN. NO ADVERSE EVENT REPORTED. 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 COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549607

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR ISORDIL 2.5MG 3 TIMES A DAY - 30 YEARS| NORVASC 5MG ONCE A DAY - 1 YEAR| CALCIUM 2 TIMES A DAY| DETROL LA 4MG ONCE A DAY - 2 YEARS| COMBIVENT 2 PUFFS TWICE A DAY - 2 YEARS| LASIX 20MG ONCE A DAY - 1 YEAR| LIPITOR 80MG ONCE A DAY - 3 YEARS| GLYBURIDE 5MG ONCE A DAY - 7 YEARS| LISINOPRIL 20MG ONCE A DAY - 1 YEAR| INDERAL LA 120 MG ONCE A DAY - 30 YEARS| ZOLTAN 1 DROP EACH EYE ONCE A - 2 YEARS| ASPIRIN 325MG ONCE A DAY - UNKNOWN| MULTIVITAMIN| CUMIN 5MG ONCE A DAY - 2 YEARS| HYDROCHLOROTHIAZIDE 12.5MG - ONCE A DAY, 5 YEARS