BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2162441 · Received July 14, 2011

    Report

    Report Number
    1823260-2011-03750
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    May 15, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTS BEING UNRESPONSIVE WITH RESULT OF 414 MG/DL OBTAINED ON THE ADVANTAGE SYSTEM WHILE USING COMFORT CURVE TEST STRIPS. PARAMEDICS WERE CALLED, AND WITHIN 10 MINUTES CUSTOMER TESTED 16 MG/DL ON PROFESSIONAL DEVICE. CUSTOMER WAS TREATED WITH AN IV (CONTENTS UNKNOWN). CUSTOMER WAS TAKEN TO THE HOSPITAL AND LEFT AFTER A FEW HOURS AFTER TESTING 80 MG/DL ON HOSPITAL DEVICE. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE HOWEVER CUSTOMER NO LONGER HAS THE TEST STRIPS; 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 ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 056 YR HUMALOG| 2 STENTS| METFORMIN TWICE DAILY| ALBUTEROL| TOPIRAMATE| METHADONE| LOSARTAN ONCE DAILY| METOPROLOL TARTRATE DAILY| VARDENAFIL ONCE DAILY| SIMVASTATIN ONCE DAILY| LANTUS| NOVOLIN 70/30 AM/PM| FUROSEMIDE| LISINOPRIL ONCE DAILY| ROPINIROLE| OMEPRAZOLE ONCE DAILY| FISH OIL