BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2036533 · Received April 1, 2011

    Report

    Report Number
    1823260-2011-01819
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    March 30, 2011
    Report Date
    May 5, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER REPORTED AVIVA BLOOD GLUCOSE RESULTS OF 18.1 MMOL/L, HI, WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS OF 33.3 MMOL/L, AND 8.2 MMOL/L WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIP LFR ROCHE DIAGNOSTICS NA 490094

    Patients

    Seq Age Sex Outcome Treatment
    1 074 YR PIOGLITAZONE 1XDAY| METFORMIN