BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2222657 · Received August 25, 2011

    Report

    Report Number
    1823260-2011-04556
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 19, 2011
    Report Date
    September 30, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2 (LOT NUMBER 551481, EXPIRATION DATE 03/31/2012). REFERENCE MEDWATCH REPORT WITH (B)(6) FOR THE SUSPECT DEVICE USED IN SYSTEM 1.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULT OF 117 MG/DL ON ADVANTAGE SYSTEM 1 AND RESULT OF 320 MG/DL ON ADVANTAGE SYSTEM 2 WITHIN 10 MINUTES. COMFORT CURVE TEST STRIPS WERE USED. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND 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 551481

    Patients

    Seq Age Sex Outcome Treatment
    1 059 YR VITAMIN D| METFORMIN 2 TIMES A DAY| GLIPIZIDE TWICE DAILY| LOSARTAN ONCE DAILY| FISH OIL| LANTUS ONCE DAILY