BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3173952 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-94801
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    September 21, 2012
    Report Date
    May 31, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED REGARDING UNEXPLAINED HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD SETTINGS WERE CORRECT. ASSISTED THE CALLER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. A TUBING CLAMP WAS NOT AVAILABLE AT TIME OF CALL TO PERFORM THE HIGH PRESSURE TEST. A FOLLOW UP WAS CONDUCTED, AND FOUND THAT THE CUSTOMER WAS IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE. THE CALLER MENTIONED HAVING A SERIOUS RENAL FAILURE, AND EVERY TIME HIS GLUCOSE LEVEL GOES HIGH, IT DOES PROGRESS THE RENAL FAILURE. THE CUSTOMER EXPERIENCED VOMITING AND DIARRHEA. THE CUSTOMER STATED THAT HE WAS RECEIVING THE TREATMENT THAT HE NEEDED AND ONCE HE HAD THE ENERGY TO LEAVE, HE GOT UP AND WALKED OUT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274292 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization