BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933137 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-86935
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HER RESERVOIR SETS ARE NOT LASTING LONGER THAN 24 HOURS AND HAS ALSO BEEN EXPERIENCING LOW BLOOD GLUCOSE READINGS FOR THREE DAYS. CUSTOMER STATED THAT HER BLOOD GLUCOSE READINGS AT LUNCH WAS 46 MG/DL AND SHE TREATED WITH A BOLUS. CUSTOMER WAS NOT ADMITTED AS AN INPATIENT FOR MEDICAL TREATMENT. TROUBLESHOOTING WAS PERFORMED AND THE DRIVE SUPPORT CAP APPEARED TO BE NORMAL. THROUGH TROUBLESHOOTING IT WAS ALSO NOTED THAT THE CUSTOMER'S SETTINGS NEED TO BE CHANGED BY HER DOCTOR. CUSTOMER REPORTED THAT THE INSULIN PUMP WAS EXPOSED TO A HIGH MAGNETIC FIELD WHEN SHE HAD HER X-RAY DONE. DISPLACEMENT TEST WAS PERFORMED AND PASSED. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 81 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409207 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR