BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1771203 · Received February 18, 2008

    Report

    Report Number
    1823260-2008-01637
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    November 30, 2007
    Report Date
    February 18, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 96 MG/DL BACK TO BACK WITH A RESULT OF 53 MG/DL ON THE ADVANTAGE SYSTEM WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. REPORTER INDICATED THAT SHE WAS NOT SURE IF SHE EXPERIENCED ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. REPORTER STATED THAT SHE SELF-TREATED WITH 3 GLUCOSE TABS. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. 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 550014

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR WELLBUTRIN XL - 15 YEARS, 150MG 3 TIMES DAILY| LANTUS - 3 YEARS, 18 UNITS ONCE DAILY| HUMALOG - 10-15 YEARS, SLIDING SCALE 3 TIMES DAILY| FOSAMAX - 10 YEARS, 70MG ONCE WEEKLY| PAXIL CR - 10 YEARS, 25MG TWICE DAILY| OMEPRAZOLE - 15 YEARS, 20MG ONCE DAILY| FOLIC ACID - 2 YEARS, 1MG ONCE DAILY| FEXOFENADINE - 15 YEARS, 180MG ONCE DAILY| LYRICA - 2 YEARS, 75MG TWICE DAILY| RISPERDAL - 3 YEARS, 0.5MG ONCE DAILY| ACETAMINOPHEN W/CODEINE - 6 YEARS, 4 TIMES DAILY| VESICARE - 3 YEARS, 5MG ONCE DAILY| TOPAMAX - 3 YEARS, 100MG TWICE DAILY| DIOVAN - 3 YEARS, 160MG ONCE DAILY| ARICEPT - 10 YEARS, 10MG ONCE DAILY| PROVIGIL - 4 MONTHS, 200MG ONCE DAILY| VERAPAMIL - 3 YEARS, 240MG ONCE DAILY| METHOTREXATE - 2 YEARS, 2.5MG 6 TABS WEEKLY