BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3900952 · Received June 27, 2014

    Report

    Report Number
    3004209178-2014-86317
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING THE PRIME TEST DUE TO A FAULTY FORCE SENSOR RESISTOR. THE DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INFUSION SET AND RESERVOIR WERE CHANGED AND DID A REWIND THREE TO FOUR TIMES WITH A COMPLETE INFUSION SET AND BATTERY CHANGE. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP WAS LOOSE. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377698 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715WWL

    Patients

    Seq Age Sex Outcome Treatment
    1