BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2070387 · Received April 19, 2011

    Report

    Report Number
    3004209178-2011-81106
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 A MOTOR ERROR ALARM OCCURRED DURING A RESERVOIR CHANGE. THE CUSTOMER STATED THAT THE INSULIN PUMP DID NOT REWIND AND THE BUTTONS WERE UNRESPONSIVE. THE CUSTOMER THEN STATED THAT THE ANOMALY PERSISTED AFTER A BATTERY CHANGE, AND THAT THERE WAS A WEAK BATTERY ALARM EVEN THOUGH THE BATTERY WAS NEW. THE CUSTOMER ALSO MENTIONED THAT THE LAST RESERVOIR LEAKED INTO THE INSULIN PUMP. NOTHING FURTHER WAS MENTIONED.

    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-722WWP

    Patients

    Seq Age Sex Outcome Treatment
    1