BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3790148 · Received May 5, 2014

    Report

    Report Number
    2032227-2014-02230
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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. THE DEVICE WILL BE RETURN FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE HAD UNEXPLAINED HIGH BLOOD GLUCOSE BECAUSE HIS INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT DELIVERING ANY INSULIN BECAUSE HE ATTEMPTED TO GIVE HIMSELF 7 UNITS OF INSULIN AND THE RESERVOIR DID NOT MOVED. CUSTOMER STATED THAT HE HAS SCLEROSIS ON THE LIVER AND HE IS HAVING A LOT OF ISSUES. CUSTOMER ALSO STATED THAT HE HAD A CAT SCAN AND AN ULTRASOUND AND HE WAS WEARING THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267528 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR