BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 3841264 · Received May 30, 2014

    Report

    Report Number
    1823260-2014-03887
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    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
    IN, US
    Reporter Occupation
    PATIENT
    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

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS WITHIN 10 MINUTES: 157 MG/DL ON THE ADVANTAGE SYSTEM AND 81 MG/DL ON THE AVIVA SYSTEM. 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
    319153 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 492218

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male AMRYL| FOSAMAX| LISINOPRIL| METFORMIN| NORVASC| PREDNISONE| TOPROL XL| VITAMIN D| ZOCOR| PREDNISONE| METFORMIN| TOPROL XL| NORVASC| LISINOPRIL| FOSAMAX| AMRYL| ZOCOR| VITAMIN D