BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA

    MDR report key: 3935442 · Received July 15, 2014

    Report

    Report Number
    1823260-2014-05245
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 16, 2014
    Report Date
    August 26, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    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 HE WAS UNABLE TO TURN THE AVIVA SYSTEM ON AND TEST HIS BLOOD GLUCOSE WHEN HE WAS NOT FEELING WELL. HE ATE CAKE AND THEN "PASSED OUT," AND HIS FRIEND CALLED AN AMBULANCE. HE WAS TRANSFERRED TO THE HOSPITAL AND ADMITTED FOR 2 DAYS. HE WAS UNABLE TO PROVIDE SPECIFIC SYMPTOMS OR WHAT BLOOD GLUCOSE RESULTS WERE OBTAINED BY THE EMTS OR HOSPITAL. HE DOES NOT KNOW IF HE WAS TREATED BY THE EMTS, AND HE ONLY REMEMBERS BEING TREATED WITH INSULIN IN THE HOSPITAL. HE WAS UNABLE TO REPORT IF HE PASSED OUT DUE TO HYPOGLYCEMIA OR HYPERGLYCEMIA. HE IS CURRENTLY FEELING BETTER. THE ALLEGED PRODUCT WAS REPLACED AND REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414171 ACCU-CHEK ® AVIVA BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR Hospitalization| R METFORMIN| LISINOPRIL| LANTUS| HUMALOG