BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2001687 · Received February 25, 2011

    Report

    Report Number
    1823260-2011-01048
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 23, 2011
    Report Date
    May 31, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN SWEDEN. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1 (LOT NUMBER 490087, EXPIRATION DATE 01/31/2012). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(4) FOR THE SUSPECT DEVICE USED IN SYSTEM 2.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 8 MMOL/L AND 8 MMOL/L ON AVIVA NANO SYSTEM 1 AND RESULT OF 4.2 MMOL/L ON AVIVA NANO SYSTEM 2 WITHIN 10 MINUTES. CUSTOMER STATES AVIVA NANO SYSTEM 1 HAD BEEN BRIEFLY EXPOSED TO EXTREME TEMPERATURES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. 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 490087

    Patients

    Seq Age Sex Outcome Treatment
    1 036 YR REPARIL| HUMALOG| LANTUS