BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA

    MDR report key: 2033594 · Received March 30, 2011

    Report

    Report Number
    1823260-2011-01697
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    January 2, 2011
    Report Date
    March 30, 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

    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 ATTEMPTED TO TEST ON THE AVIVA SYSTEM WHEN WAS HURTING ALL OVER AND FELT SICK TO HIS STOMACH BUT COULDN'T GET A RESULT DUE TO AN ERROR MESSAGE. REPORTER STATED THAT HE WAS DRIVEN TO THE HOSPITAL AND A RESULT AROUND 500-800 MG/DL WAS OBTAINED ON THEIR SYSTEM BEFORE HE WAS ADMITTED AND TREATED INTRAVENOUSLY. REPORTER STATED THAT HE WAS PUT IN A STEP DOWN UNIT OF THE HOSPITAL AND KEPT FOR 6 DAYS. 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
    1 051 YR Hospitalization| R POTASSIUM CHLORIDE (TWICE DAILY)| OXYCODONE| MAGNESIUM OXIDE (DAILY)| ALBUTEROL INHALER| ASPIRIN (DAILY)| NITROGLYCERIN| "LETROPROLOL" (TWICE DAILY)| CANE| WHEELCHAIR| WALKER| BLOOD PRESSURE CUFF (LIFE SOURCE)| VALSARTAN (TWICE DAILY)| SIMVASTATIN (DAILY)| OMEPRAZOLE (DAILY)| LEVOTHYROXINE (DAILY)| GLARGINE| ASPART| GABAPENTIN (DAILY)| CLONIDINE PATCH (WEEKLY)