BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3924380 · Received July 9, 2014

    Report

    Report Number
    2032227-2014-03487
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    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

    CUSTOMER REPORTED THAT THERE WAS AN URGENT CARE VISIT TO THE LOCAL DIABETES CENTER DUE TO HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS OVER 600 MG/DL. CUSTOMER STATED THAT HIS INSULIN PUMP WAS NOT WORKING CORRECTLY, IT WAS ALARMING NO DELIVERY AND HER INFUSION SET CANNULA WAS BENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401532 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization UNOMEDICAL INSULIN INFUSION SET