BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4050363 · Received September 1, 2014

    Report

    Report Number
    2032227-2014-15178
    Event Type
    Malfunction
    Date Received
    September 1, 2014
    Date of Event
    August 2, 2014
    Report Date
    August 19, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. 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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE, PER VARIANCE 5.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST DUE TO LOOSE PROTRUDED DRIVE SUPPORT DISK ALSO, UNABLE TO PERFORM OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST DUE TO A33 ALARM. HOWEVER, THE INSULIN PUMP PASSED OPERATING CURRENT, A21 ERROR TEST AND DISPLACEMENT TEST. THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW, CRACKED BATTERY TUBE THREADS AND MISSING THE END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER'S INSULIN PUMP IS ALARMING AND INSULIN IS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. CUSTOMER CANNOT EXIT THE PROCESS. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531721 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754WWP

    Patients

    Seq Age Sex Outcome Treatment
    1