BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2946333 · Received February 6, 2013

    Report

    Report Number
    1823260-2013-00732
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 23, 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
    MD, 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. THIS MEDWATCH IS FOR THE AVIVA SYSTEM. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT METERS, WITHIN 10 MINUTES: 184 MG/DL (COMPACT PLUS) AND 428 MG/DL (POSSIBLE AVIVA METER). CUSTOMER WAS HAVING SYMPTOMS OF STUMBLING AND GLAZED EYES. CUSTOMER WAS INCAPABLE OF SELF-TREATMENT; CUSTOMER'S BROTHER TREATED HIM WITH 12 UNITS OF NOVOLOG INSULIN BY SYRINGE BASED UPON THE READING OF 428 MG/DL. NO ADVERSE EVENT REPORTED. CUSTOMER'S BROTHER WAS UNABLE TO REPORT THE ACTUAL MODEL OF THE SECOND METER INVOLVED; THEREFORE, AN AVIVA METER HAS BEEN ASSUMED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50462 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male LANTUS| METFORMIN| NOVOLOG INSULIN| NOVOLOG INSULIN| METFORMIN| LANTUS