BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA EXPERT

    MDR report key: 7448140 · Received April 20, 2018

    Report

    Report Number
    3011393376-2018-01793
    Event Type
    Malfunction
    Date Received
    April 20, 2018
    Date of Event
    April 10, 2018
    Report Date
    July 23, 2025
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    PMA / PMN Number
    K131366
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ERRORS THAT OCCURRED IN THE SUBMISSION OF MDRS FOR INCORRECT MANUFACTURER NAME AND/OR ADDRESS. A NON-CONFORMANCE REPORT (NCR) ¿ 16847 TO IMPLEMENT CORRECTIVE ACTIONS WAS OPENED ON JANUARY 29, 2025. DEVICE PERFORMANCE AND/OR RISK PROFILE ARE NOT IMPACTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER ALLEGES INCORRECT ACTIVE INSULIN WAS DISPLAYED BY HIS METER. CALLER REPORTED THE METER SHOWED THE SAME AMOUNT OF ACTIVE INSULIN (10.8 UNITS) AT 11:34 P M AND AGAIN AT 12:39 A M. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED DEVICE FOR EVALUATION AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290816 ACCU-CHEK ® AVIVA EXPERT BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIABETES CARE, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male UNKNOWN INSULIN