BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 4162140 · Received October 10, 2014

    Report

    Report Number
    1823260-2014-07781
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 11, 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
    AZ, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. PRODUCT WAS DISCARDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 580 MG/DL, 450 MG/DL, 350 MG/DL, AND 258 MG/DL. NO ADVERSE EVENT REPORTED. THERE WERE NO REMAINING STRIPS LEFT; THEREFORE, NO STRIPS COULD BE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644907 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male CPAP MACHINE| EVERFLO| LANTUS| NOVOLOG| OMEPRAZOLE| OMEPRAZOLE| NOVOLOG| LANTUS| CPAP MACHINE| EVERFLO