BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4111146 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-23011
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP WAS DOWNLOADED PROPERLY TO CARELINK. INSULIN PUMP WAS MONITORED FOR SEVERAL DAYS AND NO UNEXPECTED PUMP SUSPENDING ANOMALY NOTED. SEVERAL A47 ALARMS WERE FOUND AT THE ALARM HISTORY FILE. THE A47 ALARMS WERE DUE TO A CORRUPTED HISTORY FILES. NO COSMETIC DAMAGE NOTED. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP DID NOT RESUME NORMAL OPERATIONS AFTER UPLOADING TO CARELINK. BLOOD GLUCOSE READING WAS 203 MG/DL. ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591421 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554CMS

    Patients

    Seq Age Sex Outcome Treatment
    1