BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3192782 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-95109
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 9, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER'S DAUGHTER CALLED TO REPORT THAT CUSTOMER IS RECEIVING INSULIN DURING THE BOLUS, NOT THE REGULAR INSULIN DELIVERY. CUSTOMER WOKE UP WITH HIGH BLOOD GLUCOSE READING AND THE RESERVOIR WAS ALMOST FULL, AFTER ONE WEEK OF USE. THE BLOOD GLUCOSE READING IS 118 MG/DL. CUSTOMER HAS EXPERIENCED HEADACHES AND LIGHTHEADED. DURING TROUBLESHOOTING, TIME AND DATE ARE INCORRECT. CORRECTED TIME AND DATE. PROGRAMMING IS CORRECT. MANUAL PRIME IS CORRECT, INSULIN EXITED THE TUBING. HIGH PRESSURE TEST FAILED TWICE. ADVISED THAT INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291644 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR