BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3981424 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-89921
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING THE PRIME TEST DUE TO A LOOSE AND PROTRUDED DRIVE SUPPORT DISK. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, A CRACKED DISPLAY WINDOW, A CRACKED RESERVOIR TUBE, CRACKED BATTERY TUBE THREADS, A BROKEN RESERVOIR TUBE LIP, A CRACKED BELT CLIP SLOT AND A STAINED END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A HIGH BLOOD GLUCOSE LEVEL OF 400 MG/DL AT THE TIME OF THE CALL. CUSTOMER STATED THAT THE HIGH BLOOD GLUCOSE WAS DUE TO HAVING HER INFUSION SET AND RESERVOIR IN FOR TOO LONG. CUSTOMER REQUESTED ASSISTANCE WITH CHANGING THESE. CUSTOMER REPORTED RECEIVING AN ERROR ALARM ON THE INSULIN PUMP. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP'S DRIVE SUPPORT CAP WAS STICKING OUT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457658 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAH A1722NAHJ

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR