BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1803120 · Received August 17, 2010

    Report

    Report Number
    1823260-2010-04882
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    August 5, 2010
    Report Date
    September 3, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE ADVANTAGE SYSTEM (LOT NUMBER 551258, EXPIRATION DATE 06/30/2011). (B)(4).

    Description of Event or Problem · 1

    DURING A RIGHT PERCUTANEOUS NEPHROLITHOTOMY, THE PHYSICIAN MADE MULTIPLE RE-STICKS. A SMALL PIECE OF THE GUIDE PORTION OFF THE SENSOR WIRE WAS SHEARED OFF IN THE RENAL FAT. THE OR PERSONNEL OPINE IT WAS BECAUSE THE PHYSICIAN WAS VERY ROUGHLY TRYING TO ADVANCE THE GUIDEWIRE. THE PATIENT WAS FINE AND DISCHARGED TO HOME. THE CASE WAS ABORTED BECAUSE ACCESS WAS UNSUCCESSFUL.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 194 MG/DL ON THE ADVANTAGE SYSTEM AND 106 MG/DL ON THE AVIVA SYSTEM WITHIN 10 MINUTES. 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 551258

    Patients

    Seq Age Sex Outcome Treatment
    1 088 YR RED YEAST RICE| LISINOPRIL| ACIDOPHILUS| METFORMIN| BABY ASPIRIN