BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1023850 · Received April 2, 2008

    Report

    Report Number
    1823260-2008-02936
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    March 24, 2008
    Report Date
    April 2, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 48 MG/DL BACK TO BACK WITH A RESULT OF 98 MG/DL ON THE VOICEMATE ADVANTAGE SYSTEM WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. REPORTER INDICATED THAT SHE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. REPORTER STATED THAT SHE TOOK HER NORMAL 30 UNITS OF LANTUS AND ATE BREAKFAST AFTER OBTAINING THE RESULTS. 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR ATENOLOL - SEVERAL YEARS - 25 MG TAB DAILY| NORVASC - SEVERAL YEARS - 5 MG TAB DAILY| BABY ASPIRIN - SEVERAL YEARS - 81 MG TAB DAILY| SYNTHROID - 8 YHEARS - 0.150 MCG TAB DAILY| NOVOLOG SLIDING SCALE| PLAVIX - 75 MG TAB DAILY| LIPITOR - SEVERAL YEARS - 10 MG TAB DAILY| LANTUS - SEVERAL YEARS - 30 UNITS DAILY| PRINIVIL - SEVERAL YEARS - 40 MG TAB DAILY| LANTUS - SEVERAL YEARS - 6-8 UNITS NIGHTLY