BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA COMBO

    MDR report key: 3932623 · Received July 14, 2014

    Report

    Report Number
    1823260-2014-05198
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 15, 2014
    Report Date
    July 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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

    IT WAS REPORTED THAT THE PATIENT ALLEGES THE ACTIVE INSULIN AMOUNT PROVIDED BY THE BLOOD GLUCOSE MONITOR WAS NOT ACCURATE. THE PATIENT STATED THAT SHE RECEIVED A BOLUS RECOMMENDATION AND CONFIRMED THE BOLUS, BUT THE INFUSION DEVICE DID NOT DELIVER THE BOLUS. THE PATIENT STATED THAT THE BLOOD GLUCOSE MONITOR THEN SHOWED THE BOLUS AS ACTIVE INSULIN, EVEN THOUGH IT HAD NOT BEEN DELIVERED. NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409545 ACCU-CHEK ® AVIVA COMBO BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female