BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2042555 · Received April 6, 2011

    Report

    Report Number
    1823260-2011-01917
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 14, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER'S CAREGIVER REPORTED THAT THE CUSTOMER HAD A BLOOD GLUCOSE RESULT OF 199 MG/DL ON THE AVIVA METER AT 5:45 P.M. CUSTOMER WAS EXHIBITING UNSPECIFIED HYPOGLYCEMIC SYMPTOMS WITH THE READING. CAREGIVER "IGNORED" THE DEVICE READING AND PREPARED A MEAL AS CUSTOMER WAS NOT ABLE TO PREPARE THE MEAL, ABOUT 6 P.M., OF GROUND TURKEY, POTATOES, AND CARROTS. CUSTOMER CONSUMED THE FOOD AND OBTAINED A READING OF 181 MG/DL AT AROUND 6:30 P.M. CUSTOMER FELT BETTER AROUND 8:30 P.M. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 303080

    Patients

    Seq Age Sex Outcome Treatment
    1 091 YR Required Intervention GLIMEPIRIDE| METOPROLOL 1X DAILY| AMLODIPINE 1X DAILY| LISINOPRIL