BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2211249 · Received August 15, 2011

    Report

    Report Number
    1823260-2011-04340
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE AVIVA NANO SYSTEM (LOT NUMBER 490240, EXPIRATION DATE 08/31/2012). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) OR THE SUSPECT DEVICE USED IN THE MOBILE SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE MOBILE SYSTEM WITHIN 10 MINUTES: 17.2 MMOL/L, 7.7 MMOL/L, 6.6 MMOL/L, 5.6 MMOL/L, AND 18.2 MMOL/L. CUSTOMER TESTED 6.8 MMOL/L ON THE AVIVA NANO SYSTEM WITHIN 10 MINUTES OF THE MOBILE RESULTS. CUSTOMER INJECTED AN UNSPECIFIED ONCE DAILY LONG-ACTING INSULIN. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.

    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 490240

    Patients

    Seq Age Sex Outcome Treatment
    1 054 YR UNKNOWN INSULIN