BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3485829 · Received November 25, 2013

    Report

    Report Number
    1823260-2013-07260
    Event Type
    Malfunction
    Date Received
    November 25, 2013
    Date of Event
    November 1, 2013
    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
    MT, 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 PLUS SYSTEM BLOOD GLUCOSE RESULTS ON (B)(6) 2013: 137 MG/DL - 11:15 AM 94 MG/DL - 11:14 AM 173 MG/DL - 11:13 AM 153 MG/DL - 11:12 AM NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611732 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 492109

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female METFORMIN| PRENATAL VITAMIN| METFORMIN| PRENATAL VITAMIN