BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2882391 · Received December 20, 2012

    Report

    Report Number
    1823260-2012-06458
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 21, 2012
    Report Date
    February 15, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. (B)(4). ABSENT THE DEVICE LOT NUMBER, MANUFACTURE DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 335 MG/DL ON AVIVA SYSTEM 1, 135 MG/DL ON AVIVA SYSTEM 2 WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE STRIPS, REPLACEMENT SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR UNSPECIFIED CHOLESTEROL MEDICATION| BLOOD PRESSURE METER| GLIPIZIDE| NOVOLIN 2XDAY| UNSPECIFIED HIGH BLOOD PRESSURE MEDICATION