BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3251668 · Received July 29, 2013

    Report

    Report Number
    1823260-2013-04507
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 29, 2013
    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
    PATIENT
    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

    CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULTS OF 87 MG/DL AND 294 MG/DL, PROFESSIONAL SYSTEM RESULT OF 45 MG/DL WITHIN 10 MINUTES. AROUND 4 AM, THE CUSTOMER AWAKENED AND COULD NOT STAND UP, SPEECH WAS SLURRED. CUSTOMER CALLED HIS PARENTS AND THEY CAME TO CUSTOMER'S HOUSE AND CALLED PARAMEDICS. PARAMEDICS ARRIVED AROUND 730 AM. THE PARAMEDICS CHECKED ON THEIR METER AND THE READING WAS 45 MG/DL. CUSTOMER CHECKED ON HIS METER AND GOT READINGS OF 87 MG/DL AT 7:31 AM AND 294 MG/DL AT 7:33 AM. PARAMEDICS RECOMMENDED CUSTOMER EAT SOMETHING. CUSTOMER'S DAD GAVE HIM COOKIES AND A SPOONFUL OF SUGAR. CUSTOMER WAS NOT ABLE TO RETRIEVE THE FOOD ON HIS OWN BUT WAS ABLE TO CONSUME THE FOOD. A COUPLE HOURS LATER CUSTOMER FELT BETTER. 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
    352182 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491615

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male B12| CARVEDILOL| DEFIBRILLATOR| FUROSEMIDE| LISINOPRIL| PLAVIX| ROSUVASTATIN| STENT| WARFARIN| DEFIBRILLATOR| LISINOPRIL| ROSUVASTATIN| B12| PLAVIX| WARFARIN| STENT| FUROSEMIDE| CARVEDILOL