BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2812808 · Received October 31, 2012

    Report

    Report Number
    3004209178-2012-90412
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN 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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH MOTOR ERROR STUCK IN MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY. MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP ALARMED MOTOR ERROR. IT WAS STATED THAT THE DEVICE WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. THE DISPLACEMENT TEST WAS PERFORMED AND THE TEST FAILED. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP LZG LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715WWS

    Patients

    Seq Age Sex Outcome Treatment
    1