BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4160199 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25990
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 20, 2014
    Report Date
    July 26, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH NORMAL OPERATING CURRENTS, PASSED UNEXPECTED RESTART ERROR TEST, SELF-TEST, AND THE DISPLACEMENT TEST. HOWEVER, INSULIN PUMP ALARMED PRIME DURING THE BASIC OCCLUSION TEST DUE TO LOOSE/PROTRUDED DRIVE SUPPORT DISK. WE WERE UNABLE TO PERFORM THE OCCLUSION TEST, PRIME TEST, AND EXCESSIVE NO DELIVERY TEST DUE TO PRIME ALARM. THE INSULIN PUMP WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, CRACKED CASE AT THE RESERVOIR TUBE WINDOW CORNER, MINOR SCRATCHED LCD WINDOW, MISSING END CAP STICKER, AND SCRATCHED RESERVOIR TUBE WINDOW.

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY, IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSULIN PUMP WAS STUCK IN REWIND LOOP AND WON'T DETECT THE RESERVOIR. NO ALARMS WERE NOTED ON THE DEVICE, BUT INSULIN CONTINUES TO SQUIRT OUT. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER'S BLOOD GLUCOSE WAS NOT CAPTURED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581427 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-522CAS

    Patients

    Seq Age Sex Outcome Treatment
    1