BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3883681 · Received June 19, 2014

    Report

    Report Number
    2032227-2014-03090
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    March 20, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY CALLED STATING THAT HER INFUSION SET WAS LEAKING INSULIN AT THE QUICK RELEASE. CUSTOMER STATED THAT SHE REWIND HER INSULIN PUMP WITH THE RESERVOIR IN PLACE AND NOTICE THAT 100 UNITS OF INSULIN WAS MISSING. CUSTOMER STATED THAT SHE WENT TO THE HOSPITAL BECAUSE HER BLOOD GLUCOSE WAS 265 MG/DL AND DROPPED TO 94 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359868 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization UNOMEDICAL INSULIN INFUSION SET