BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA

    MDR report key: 1924232 · Received December 14, 2010

    Report

    Report Number
    1823260-2010-07416
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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.

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER WAS THROWING UP, OUT OF IT, COULD NOT TALK, AND NOT FEELING WELL WHEN HE ATTEMPTED TO TEST ON THE AVIVA SYSTEM, BUT ONLY GOT ERROR MESSAGES. REPORTER STATED THAT SHE TOOK HIM TO THE EMERGENCY ROOM, HE WAS TESTED,GOT A READING OVER 500 MG/DL THERE, AND WAS TREATED IN AN UNSPECIFIED WAY. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention