BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3022011 · Received March 26, 2013

    Report

    Report Number
    2032227-2013-01149
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A PROTRUDED/LOOSE MOTOR SUPPORT DISK. NO ALARMS WERE NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ALARM DURING THE REWIND PROCESS. TROUBLESHOOTING WAS PERFORMED, AND THE CUSTOMER WAS ABLE TO PROGRAM A TEST BOLUS. HOWEVER, THE BOLUS DID NOT RECORD IN THE BOLUS HISTORY. THE CUSTOMER PROGRAMMED A SECOND TEST BOLUS, AND AGAIN, IT DID NOT RECORD IN THE BOLUS HISTORY. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124674 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR