BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 4841658 · Received June 12, 2015

    Report

    Report Number
    3011393376-2015-01121
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 22, 2015
    Report Date
    July 29, 2025
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. REFERENCE THE FOLLOWING MEDWATCHES WITH PATIENT IDENTIFIERS FOR THE FOLLOWING SYSTEMS: (B)(4) - SYSTEM 1; (B)(4) - SYSTEM 2. DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY VIAL WAS RETURNED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT AVIVA METERS, WITHIN 10 MINUTES: 89 MG/DL (SYSTEM 1) AND 170 MG/DL (SYSTEM 2). NO ADVERSE EVENT REPORTED. RETURN OF SUSPECT DEVICE WAS REQUESTED AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384994 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIABETES CARE, INC. NA 494145

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male METFORMIN| VITAMIN E| METFORMIN| VITAMIN E