BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 4170037 · Received October 14, 2014

    Report

    Report Number
    1823260-2014-07856
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 15, 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
    MI, 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

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 383 MG/DL, 210 MG/DL, 420 MG/DL, AND 110 MG/DL. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650890 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 493813

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male BACTRIM| CELLCEPT| FLOMAX| HUMALOG| LABETALOL| LANTUS| PREDNISONE| PROCARDIA| PROGRASS| SODIUM BICARBONATE| PROGRASS| LANTUS| HUMALOG| PROCARDIA| BACTRIM| SODIUM BICARBONATE| CELLCEPT| PREDNISONE| FLOMAX| LABETALOL