BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3041287 · Received April 8, 2013

    Report

    Report Number
    1823260-2013-02151
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 12, 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
    TX, 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 HER HUSBAND HAD SYMPTOMS OF HYPOGLYCEMIA, WITH AN AVIVA COMBO SYSTEM BLOOD GLUCOSE RESULT OF 26 MG/DL AT 3:58 PM. CUSTOMER'S WIFE CALLED HIS TRAINER AND WAS ADVISED TO GIVE HIM SODA WITH A SPOON OF SUGAR. CUSTOMER WAS NOT ABLE TO SELF-TREAT. SHE TESTED HIM AGAIN WITH THE AVIVA COMBO SYSTEM AT 4:17 PM AND HIS RESULT WAS 31 MG/DL. SHE THEN GAVE HIM THE SODA WITH SUGAR, AND THEN MADE HIM A GRILLED CHEESE SANDWICH TO EAT. SAME SYSTEM RETEST RESULT AT 4:27 PM WAS 225 MG/DL; AT 4:42 PM, 138 MG/DL. HE WAS FEELING BETTER IN ABOUT 30 MINUTES. CONTROLS WERE SENT TO CHECK METER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143910 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491612

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male HUMALOG INSULIN| INSULIN PUMP- SPIRIT COMBO| INSULIN PUMP- SPIRIT COMBO| HUMALOG INSULIN