BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA

    MDR report key: 3030605 · Received April 2, 2013

    Report

    Report Number
    1823260-2013-01971
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 5, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    CALLER REPORTED AN INCIDENT OF HYPERGLYCEMIA REQUIRING HOSPITALIZATION WITHIN 24 HOURS OF HAVING ATTEMPTED UNSUCCESSFULLY TO USE THE AVIVA SYSTEM DUE TO ERROR E-9. ON THE DAY OF THE EPISODE THE CUSTOMER'S FRIEND CALLED THE AMBULANCE, BECAUSE SHE WAS THROWING UP, AND NOT ABLE TO SELF TREAT. THE CUSTOMER LAST USED THE METER ON SUNDAY OR MONDAY OF THIS WEEK. HER READING WAS HIGH AT THE TIME OF THE TEST. CUSTOMER BELIEVES THE METER READ AROUND 600. AFTER THE LAST READING OF 600, CUSTOMER ATTEMPTED TO USE THE METER, AND EACH TIME SHE TRIED TO USE THE METER, SHE KEPT GETTING E-9 ON THE DISPLAY, AND SHE WAS NOT ABLE TO GET A RESULT. THE LAST TIME SHE USED THE METER SUCCESSFULLY WAS EITHER (B)(6) BEFORE INCIDENT OF (B)(6) 2013. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134234 ACCU-CHEK ® AVIVA BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 054 YR Hospitalization ONEADAY VITAMINS| OMEPRAZOLE| AMIODARONE| FLONASE| HUMALOG| LANTUS| ASPIRIN| SIMVASTATIN