BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA

    MDR report key: 2122025 · Received June 13, 2011

    Report

    Report Number
    1823260-2011-03211
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    June 2, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 ATTEMPTED TO USE THE AVIVA SYSTEM, BUT GOT AN ERROR MESSAGE AND THEN BECAME INCAPABLE OF TREATMENT DUE TO HYPOGLYCEMIA IN THE NEXT 24 HOURS. THE CUSTOMER WAS UNRESPONSIVE. REPORTER STATED THE PARAMEDICS WERE CALLED, THEY OBTAINED A 34 MG/DL ON THEIR SYSTEM AND TREATED THE CUSTOMER WITH GLUCOSE INTRAVENOUSLY. 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
    1 090 YR Required Intervention NOVOLIN (TWICE DAILY)