BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4103831 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26714
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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. 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

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH PROTRUDED/LOOSE DRIVE SUPPORT DISK, MISSING END CAP STICKER, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, BROKEN BELT CLIP SLOT AT BATTERY TUBE THREADS AREA AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE DRIVE SUPPORT CAP OF THE INSULIN PUMP WAS LOOSE. THE CUSTOMER HAD NOT PRESSED THE CAP WHILE CONNECTED TO THE INSULIN PUMP. THE INSULIN PUMP HAD NOT BEEN DROPPED OR BUMPED. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581823 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754WWP

    Patients

    Seq Age Sex Outcome Treatment
    1