BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2111409 · Received June 2, 2011

    Report

    Report Number
    1823260-2011-02933
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 12, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER WAS UNABLE TO OBTAIN THIS INFORMATION IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER STATES CUSTOMER WAS UNABLE TO OBTAIN A RESULT ON THE AVIVA SYSTEM DUE TO AN ERROR ON THE DEVICE. CALLER STATES CUSTOMER WAS HOSPITALIZED AND TREATED FOR HYPERGLYCEMIA. NO FURTHER DETAILS AVAILABLE. 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 302434

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O