BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1970389 · Received January 25, 2011

    Report

    Report Number
    1823260-2011-00382
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 27, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULTS OF 356 MG/DL AND 145 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.

    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 302832

    Patients

    Seq Age Sex Outcome Treatment
    1 081 YR ECOTRIN 1XDAY| LANTUS 1XDAY| STOOL SOFTENER 1XDAY| IRON 1XDAY| FOLNATE PLUS 1XDAY| METFORMIN 3XDAY| "CARVELDELO" 2XDAY| PRESERVISION 1XDAY| SIMVASTATIN 1XDAY| "ASOSPHBIDE"| PLAVIX 1XDAY