BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1810306 · Received August 20, 2010

    Report

    Report Number
    1823260-2010-05000
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    August 12, 2010
    Report Date
    September 3, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULTS OF HI, WHICH ON THE AVIVA SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL, 170 MG/DL, AND 360 MG/DL WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 302329

    Patients

    Seq Age Sex Outcome Treatment
    1 066 YR LANTUS SOLO STAR 1XDAY| HUMALOG SLIDING SCALE