BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA

    MDR report key: 2441118 · Received February 7, 2012

    Report

    Report Number
    1823260-2012-00686
    Event Type
    Injury
    Date Received
    February 7, 2012
    Date of Event
    January 20, 2012
    Report Date
    February 7, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER ATTEMPTED TO TEST ON THE AVIVA SYSTEM WHEN SHE WAS NAUSEOUS BUT COULD NOT GET A RESULT DUE TO AN ERROR MESSAGE. REPORTER STATED THAT HE TOOK THE CUSTOMER TO THE HOSPITAL AND SHE WAS TREATED FOR VOMITING AND GIVEN INSULIN. REPORTER STATED SHE FELT DIZZY UPON ARRIVAL TO THE HOSPITAL AND A CAT SCAN WAS DONE. REPORTER STATED SHE WAS ADMITTED TO THE HOSPITAL AND RELEASED ON (B)(6) 2012. 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 Hospitalization| R NOVOLOG (DAILY)