BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3895481 · Received June 25, 2014

    Report

    Report Number
    3004209178-2014-86125
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP OVER-DELIVERED INSULIN. THE INSULIN PUMP DELIVERED INSULIN THAT WAS NOT PROGRAMMED BY THE CUSTOMER. THE INFUSION SET WAS CHANGED TWO DAYS PRIOR TO THE INCIDENT. CUSTOMER DID NOT REWIND OR PRIME THE INSULIN PUMP. NO ACCIDENTAL BUTTON PRESSING OCCURRED. CUSTOMER ALSO STATED THAT 22.5 UNITS WAS TO BE DELIVERED, HOWEVER, HE DID NOT PROGRAM THIS AMOUNT. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370208 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722CAB

    Patients

    Seq Age Sex Outcome Treatment
    1