BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1935057 · Received December 22, 2010

    Report

    Report Number
    1823260-2010-07607
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 19, 2010
    Report Date
    July 18, 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). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1 (LOT NUMBER 202807, EXPIRATION DATE 12/31/2011). (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 28.9 MMOL/L ON AVIVA SYSTEM 1 AND 8.9 MMOL/L ON AVIVA SYSTEM 2 WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    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
    1 057 YR TRAZODONE ONCE A DAY| "RADETRAZOLAEC" ONCE A DAY| LISINOPRIL ONCE A DAY| ASA ONCE A DAY| "CETRIZINA" ONCE A DAY| SYNTHROID ONCE A DAY| "FLUVOXANINA" ONCE A DAY| PRAVASTATIN ONCE A DAY| METOPROLOL TWICE DAILY| INDAPAMIDE TWICE DAILY| METFORMIN TWICE DAILY