BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4201262 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-42141
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT HAD MULTIPLE A47 ALARM IN ALARM HISTORY SCREEN DUE TO CORRUPTED HISTORY FILE. UNABLE TO UPLOAD USING CARELINK PRO AND CARELINK PERSONAL DUE TO CORRUPTED HISTORY FILE. UNIT HAD A SMALL CRACK ON THE RESERVOIR TUBE LIP.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

    CUSTOMER REPORTED THAT THE INSULIN PUMP COULD NOT BE DOWNLOADED INTO CARELINK. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP BECAME UNRESPONSIVE WITH RETURNING A PRIOR ALARM. BLOOD GLUCOSE LEVEL WAS 200 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682315 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWH

    Patients

    Seq Age Sex Outcome Treatment
    1