BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3883696 · Received June 19, 2014

    Report

    Report Number
    2032227-2014-03072
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    February 14, 2011
    Report Date
    May 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 INITIALLY CALLED TO REPORT THAT SHE HAD HIGH BLOOD GLUCOSE AND HAS CHANGED THE INFUSION SET THREE TIMES. CUSTOMER STATED THAT SHE WAS ABLE TO BRING THE BLOOD GLUCOSE DOWN WITH A MANUAL INJECTION. CUSTOMER MENTIONED THAT SHE WAS HOSPITALIZED IN INTENSIVE CARE UNIT 3 YEARS AGO DUE TO HIGH BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE WAS 600 MG/DL AT THE TIME OF ADMISSION. CUSTOMER STATED THAT SHE HAD CHEST PAINS AND TROUBLE BREADING PRIOR TO HOSPITALIZATION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359880 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization UNOMEDICAL INSULIN INFUSION SET