BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 4220257 · Received November 3, 2014

    Report

    Report Number
    1823260-2014-08447
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    September 29, 2014
    Report Date
    July 29, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    WIFE REPORTED THE CUSTOMER WAS FOUND ON THE FLOOR MUMBLING, INCOHERENT, AND "OUT OF HIS HEAD" AROUND 3:00 A.M. SHE TESTED HIS BLOOD GLUCOSE AND THE RESULT WAS 121 MG/DL. SHE CALLED 911, AND THE FIRST RESPONDERS ARRIVED WITHIN A FEW MINUTES. THEY TESTED HIS BLOOD GLUCOSE, AND SHE BELIEVES THE RESULT WAS 38 MG/DL. THE PARAMEDICS ARRIVED AND STARTED A GLUCOSE IV, AND HE WAS TRANSPORTED TO THE HOSPITAL. HE WAS ADMITTED TO THE HOSPITAL FOR 3 DAYS AND TREATED FOR HYPOGLYCEMIA AND AN OPEN WOUND FROM A HERNIA SURGERY. THE CAUSE OF HYPOGLYCEMIA IS NOT KNOWN; HE HAD NOT TAKEN ADDITIONAL INSULIN BASED ON A METER RESULT. THE ALLEGED PRODUCT WAS REPLACED AND REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701946 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 492073

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male BLOOD PRESSURE CUFF| BLOOD SUGAR METER| HUMALOG| LEVEMIR| OXYGEN| OXYGEN| HUMALOG| BLOOD SUGAR METER| LEVEMIR| BLOOD PRESSURE CUFF