BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2251519 · Received September 16, 2011

    Report

    Report Number
    1823260-2011-04907
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 23, 2011
    Report Date
    October 3, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 DAUGHTER STATES THAT THE CUSTOMER HAD A HYPOGLYCEMIC INCIDENT AND ATTEMPTED TO TEST ON HER AVIVA METER, BUT WAS UNABLE TO OBTAIN A READING DUE TO AN ERROR MESSAGE. CUSTOMER WAS HOME ALONE AT BEDTIME WHEN SHE FELT HYPOGLYCEMIC SYMPTOM OF DIZZINESS. CUSTOMER FELL IN THE KITCHEN, BUT WAS ABLE TO CRAWL TO THE BEDROOM TO CALL HER DAUGHTER. CUSTOMER THEN BECAME UNCONSCIOUS. DAUGHTER ARRIVED AND ATTEMPTED TO TEST THE CUSTOMER ON THE AVIVA METER, BUT OBTAINED AN ERROR. CUSTOMER REGAINED CONSCIOUSNESS AND DAUGHTER GAVE HER ICE CREAM. CUSTOMER WAS ABLE TO CONSUME THE ICE CREAM. DAUGHTER ATTEMPTED TO RETEST THE CUSTOMER BUT CONTINUALLY RECEIVED THE ERROR MESSAGE. CUSTOMER FEELS TIRED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, 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 303069

    Patients

    Seq Age Sex Outcome Treatment
    1 077 YR Required Intervention LEVIMIR| ANTIVERT| NOVOLOG