BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4153759 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-35310
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    THE INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST DUE TO LOOSE AND PROTRUDED DRIVE SUPPORT DISK. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, A CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW, A MISSING END CAP STICKER AND CRACKED BATTERY TUBE THREADS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED DURING PRIME AND INSULIN WAS SQUIRT OUT OF THE TUBING. CUSTOMER WAS DISCONNECTED DURING PRIME. IT WAS STATED THAT THE PISTON CONTINUE TO MOVE FORWARD AFTER RESERVOIR CONTACT. NO NUMBERS APPEARED ON SCREEN AND NO BEEPS HEARD. THE INSULIN PUMP WAS NOT BUMPED, DROPPED OR EXPOSED TO MOISTURE. DRIVE SUPPORT CAP APPEARS NORMAL; END CAP STICKER DETACHED. BLOOD GLUCOSE VALUE IS 156 MG/DL. NOTHING FURTHER REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632215 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522WWL

    Patients

    Seq Age Sex Outcome Treatment
    1