BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3093677 · Received May 6, 2013

    Report

    Report Number
    2032227-2013-01658
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 8, 2013
    Report Date
    March 7, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. INSULIN PUMP PASSED DISPLACEMENT TEST, UNEXPECTED RESTART ERROR TEST, BASIC OCCLUSION, OCCLUSION TEST AND PRIME/COMPROMISED FORCE SENSOR SYSTEM. UNIT WAS MONITORED AND NO EXTERNAL ERROR ALARM NOTED. UNIT WAS RECEIVED WITH CRACKED BATTERY TUBE THREADS. DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THE DRIVE SUPPORT CAP IS PROTRUDED. CUSTOMER ALSO RECEIVED AN ERROR ALARM. ADVISED CUSTOMER THAT THE INSULIN PUMP MUST BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196871 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR