BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA

    MDR report key: 2223558 · Received August 25, 2011

    Report

    Report Number
    1823260-2011-04574
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 30, 2011
    Report Date
    December 15, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT SHE GOT AN ERROR MESSAGE ON THE AVIVA METER AND WHILE WAITING FOR IT TO TURN OFF, SHE PASSED OUT OR BLACKED OUT. REPORTER STATED THAT HER FAMILY CALLED THE PARAMEDICS WHO OBTAINED A 20 MG/DL RESULT ON THEIR SYSTEM ANT TREATED HER WITH GLUCAGON BEFORE TAKING HER TO THE HOSPITAL. REPORTER STATED THAT SHE WAS GIVEN ORANGE JUICE AT THE HOSPITAL. REPORTER ALSO STATED THAT SHE DOES NOT REMEMBER IF SHE TOOK HER INSULIN SHOT AFTER EATING AND SHE MAY HAVE TAKEN IT TWICE THAT DAY. 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
    1 082 YR Required Intervention NOVOLOG| LANTUS