BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1983367 · Received February 10, 2011

    Report

    Report Number
    1823260-2011-00750
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    February 8, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: HI (GREATER THEN 33.3 MMOL/L), 3.4 MMOL/L, 11.9 MMOL/L, AND 5.8 MMOL/L. LOW BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THESE RESULTS. CUSTOMER WAS ALE TO SELF-TREAT WITH 250 ML JUICE AND WENT BACK TO BED. NO ADVERSE EVENT RELATED TO THE DEVICE WAS 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 202807

    Patients

    Seq Age Sex Outcome Treatment
    1 029 YR ASA| HUMALOG| HUMULIN N| MATERNA VITAMIN| FOLIC ACID| SYNTHROID