BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2950630 · Received February 8, 2013

    Report

    Report Number
    2032227-2013-00531
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 20, 2013
    Report Date
    January 20, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    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

    THE CUSTOMER REPORTED A MAX DELIVERY ALARM, AND WAS VERY CONCERNED THAT THE INSULIN MAY HAVE GIVEN HER TOO MUCH INSULIN. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE LEVELS HAVE DROPPED TO 112 MG/DL, AND KEPT ASKING IF SHE SHOULD SEEK MEDICAL ASSISTANCE. THE CUSTOMER'S FIANCE' TOOK OVER THE CALL, AND THE SITUATION WAS EXPLAINED TO HIM. THE FIANCE' WAS ADVISED THAT THE CUSTOMER MIGHT NEED TO SEEK MEDICAL ASSISTANCE. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED DUE TO THE CUSTOMER'S CONCERN THAT IT MAY HAVE DELIVERED TOO MUCH INSULIN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53968 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR