BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3934382 · Received July 15, 2014

    Report

    Report Number
    2032227-2014-03909
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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. 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

    CUSTOMER'S FATHER CALLED TO CHECK THE BASAL RATES. THE CUSTOMER IS EXPERIENCING HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING IS 270 MG/DL. CUSTOMER TREATED WITH BOLUS. DURING TROUBLESHOOTING, DURING THE MANUAL PRIME PROCESS, THE INSULIN DID NOT EXIT THE INFUSION SET. NO LEAKS FOUND. CALLER DECLINED TO TROUBLESHOOT THE REST OF INSULIN PUMP. CALLER STATED THAT HE WILL TALK TO PHYSICIAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412667 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR