BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3963014 · Received July 29, 2014

    Report

    Report Number
    1823260-2014-05624
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    May 26, 2014
    Report Date
    July 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    CALLER REPORTED ROUTINE 2:00AM BLOOD GLUCOSE TEST RESULTS OF 72 MG/DL ON AVIVA SYSTEM 1, 16 MG/DL ON AVIVA SYSTEM 2 WITHIN 10 MINUTES. THE CUSTOMER WAS EXPERIENCING LOW BLOOD SUGAR SYMPTOMS. CUSTOMER'S MOTHER CONTACTED THE LOCAL HOSPITAL AND WAS INSTRUCTED TO ADMINISTER 50ML GLUCAGON. AFTER ADMINISTERING GLUCAGON, THE CUSTOMER'S MOTHER CALLED 911. WHEN THE EMTS ARRIVED THEY TESTED THE CUSTOMER'S BLOOD SUGAR AND THE RESULT WAS IN THE 70S MG/DL. THE EMTS STARTED IV FLUIDS AND ADMINISTERED ZOFRAN FOR NAUSEA. CUSTOMER TRANSPORTED BY AMBULANCE TO LOCAL HOSPITAL AT 3:00AM. WHILE AT THE HOSPITAL, FLUIDS WERE ADMINISTERED BY IV. CUSTOMER ATTEMPTED TO CONSUME JUICE BUT VOMITED. THE HOSPITAL DETERMINED THEY WERE NOT ABLE TO ADEQUATELY TREAT THE CUSTOMER AND TRANSFERRED HER TO (B)(6) HOSPITAL WHERE SHE WAS ADMITTED FOR 3 DAYS. STRIPS ARE NOT AVAILABLE FOR RETURN, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442542 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Female FLINTSTONES VITAMINS| HUMALOG| HUMULIN 70/30| SYNTHROID| HUMALOG| HUMULIN 70/30| FLINTSTONES VITAMINS| SYNTHROID