BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA

    MDR report key: 2223559 · Received August 25, 2011

    Report

    Report Number
    1823260-2011-04575
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 25, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT SHE ATTEMPTED TO TEST THE CUSTOMER WITH THE AVIVA SYSTEM WHEN SHE FOUND HIM VERY LETHARGIC. REPORTER ALLEGED THAT SHE COULD NOT OBTAIN A RESULT AS IT PRODUCED AN ERROR MESSAGE SO SHE TREATED HIM WITH JUICE. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    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
    1 072 YR Required Intervention MULTIVITAMINS| FERROUS SULFATE| LEVETIRACETAM| FEEDING TUBE