BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1833806 · Received September 14, 2010

    Report

    Report Number
    1823260-2010-05425
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    July 28, 2010
    Report Date
    May 18, 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).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA NANO SYSTEM WITHIN 10 MINUTES: 18.1 MMOL/L, 10.4 MMOL/L, AND 6.9 MMOL/L. 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 302601

    Patients

    Seq Age Sex Outcome Treatment
    1 051 YR GINKGO BILOBA ONCE DAILY| OMEGA 3 ONCE DAILY| CLONAZEPAM TWICE DAILY| PRAMIPEXOLE 4 TABS AT BEDTIME| VITAMIN D ONCE DAILY| CALCIUM TWICE DAILY| TOPIRAMATE TWICE DAILY| UNKNOWN ANTIDEPRESSANT| DIAMICRON ONCE DAILY| QUETIAPINE ONCE A DAY| METFORMIN TWICE DAILY| CRESTOR ONCE DAILY| MULTIVITAMIN ONCE DAILY