BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1792077 · Received August 10, 2010

    Report

    Report Number
    1823260-2010-04747
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 16, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 160 MG/DL AND 88 MG/DL WITHIN 10 MINUTES ON THE ACCU-CHEK SYSTEM. REPORTED A SECOND, SEPARATE COMPARISON OF BLOOD GLUCOSE RESULTS OF "IN THE 300'S" MG/DL AND "100'S" MG/DL WITHIN 10 MINUTES ON THE SAME SYSTEM. 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN A CALCIFIED AND MODERATELY TORTUOUS SUBCLAVIAN VEIN. THE F/G, STERLING, MR, 3.0 X 20/135 (4F) BALLOON WAS USED FOR PREDILATATION. ON THE FIRST INFLATION THE BALLOON RUPTURED AT TEN ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT STATUS IS LISTED AS GOOD WITH NO COMPLICATIONS REPORTED.

    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 302613

    Patients

    Seq Age Sex Outcome Treatment
    1 051 YR METFORMIN| CPAP| SIMVASTATIN 1XDAY| LISINOPRIL| TRILIPIX 1XDAY