BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3980985 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-89973
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    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

    THE REPORTER STATED THAT HER DAUGHTER WAS HOSPITALIZED ON (B)(6) 2014 DUE TO HIGH BLOOD GLUCOSE. BLOOD GLUCOSE READING AT THE TIME WAS 630 MG/DL. THE REPORTER'S DAUGHTER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE HOSPITALIZATION. THE CAUSE OF THE HOSPITALIZATION WAS DETERMINED TO BE DIABETIC KETOACIDOSIS. THE DAUGHTER HAS BEEN TREATED WITH INSULIN DRIP. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS FOUND TO BE FUNCTIONING AS DESIGNED. ADVISED THE REPORTER TO CHANGE RESERVOIR, COMPLETE SET AND INSULIN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457289 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization