BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3942797 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04440
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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

    IT WAS REPORTED THAT THE CUSTOMER REPEATEDLY RECEIVED NO DELIVERY ALARMS ON HIS INSULIN PUMP. THE CUSTOMER VERIFIED THAT THE RESERVOIR WAS NOT EMPTY. HIS BLOOD GLUCOSE WAS AT 163 MG/DL. THE CUSTOMER ALSO MADE MENTION OF CRAMPS IN THE HANDS, THUMBS AND LEGS, BUT STATED HE DID NOT BELIEVE THIS WAS DUE TO DIABETES. THE CUSTOMER STATED HE WAS ABLE TO PRIME AFTER A SET CHANGE AND EXPERIENCED NO FURTHER ALARMS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419858 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR