BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 1981339 · Received February 2, 2011

    Report

    Report Number
    3004209178-2011-80289
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 22, 2011
    Report Date
    January 22, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP DID NOT DELIVER THE BOLUSES AND DID NOT ALARM. IT WAS STATED THAT THE INFUSION SET WAS CHANGED AND THE CUSTOMER'S BLOOD GLUCOSE WERE STILL HIGH. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE CUSTOMER WAS ILL, WHICH MAY HAVE CAUSED TO RISE THE GLUCOSE LEVEL. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722WWL

    Patients

    Seq Age Sex Outcome Treatment
    1