BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2120016 · Received June 10, 2011

    Report

    Report Number
    1823260-2011-03184
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH IS FOR THE AVIVA METER (B)(4). REFERENCE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE AVIVA METER (B)(4).

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 136 MG/DL, 134 MG/DL (AVIVA (B)(4)) AND 72 MG/DL, 71 MG/DL (AVIVA (B)(4)) CUSTOMER FELT A LITTLE SHAKEY BUT FELT BETTER AFTER EATING A BOWL OF OATMEAL. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, 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 303181

    Patients

    Seq Age Sex Outcome Treatment
    1 080 YR NOVOLIN N| METFORMIN