BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1903672 · Received November 20, 2010

    Report

    Report Number
    1823260-2010-06870
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    November 8, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THERE WERE MISSING WARNING AND HAZARD LABELS. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AVIVA RESULT AT 2:48 PM OF 31 MG/DL; REPORTED NO SYMPTOMS, BUT SHE DID DRINK SOME JUICE. SHE STATED CAN'T TELL WHEN HER BLOOD SUGAR IS LOW. SHE STATED HER NEIGHBOR CALLED HER, NEIGHBOR DIDN'T THINK SOUNDED RIGHT, AND SO CAME TO THE CUSTOMER'S HOME. THE CUSTOMER LET HER IN THE HOUSE, BUT THE CUSTOMER WAS NOT ANSWERING QUESTIONS, SEEMED TO HAVE A CHANGE IN PERSONALITY. THE CUSTOMER SAT DOWN, CLOSED HER EYES. HER BREATHING BECAME SHALLOW AND SHE STARTED TO SWEAT. THE NEIGHBOR CALLED 911 AT 3:30 PM. CUSTOMER'S AVIVA SYSTEM BLOOD GLUCOSE RESULT WAS 152 MG/DL, EMT SYSTEM RESULT WITHIN 2 MINUTES WAS 20 MG/DL. EMTS TREATED HER WITH 2 GLUCAGON SHOTS, TRANSPORTED HER TO HOSPITAL. EMT TESTED HER BLOOD SUGAR AGAIN WHEN SHE ARRIVED AT THE HOSPITAL, RESULT WAS 32 MG/DL. SHE WAS GIVEN AN UNKNOWN IV AT THE HOSPITAL, STAYED AT THE HOSPITAL FOR 4-6 HOURS. BEFORE LEAVING THE HOSPITAL HER READING WAS EITHER 292 MG/DL OR 297 MG/DL. 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
    1 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 302594

    Patients

    Seq Age Sex Outcome Treatment
    1 054 YR Required Intervention NOVOLOG| INSULIN PUMP| ALUPENT| SYNTHROID 1XDAY