BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3081681 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-92777
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 PASSED DISPLACEMENT TEST, BASIC OCCLUSION AND PRIME TESTS. THE INSULIN PUMP RECEIVED STUCK IN MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY. THE 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 IS REPORTED THAT INSULIN PUMP ALARMED MOTOR ERROR. NO EXPOSURE TO HIGH MAGNETIC FIELDS. THE INSULIN PUMP FAILED THE DISPLACEMENT TEST. MOTOR ERROR OCCURED DURING PRIME. CUSTOMER CHANGE INFUSION SET AND RESERVOIR, MOTOR ERROR ALARM PERSISTED. ASK CUSTOMER TO RETURN THE INSULIN PUMP FOR ANALYSIS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185628 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522WWB

    Patients

    Seq Age Sex Outcome Treatment
    1