BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4150332 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-35038
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT ALARMED A21 AFTER BATTERY CHANGE DUE TO C13 I/B LEAKING VOLTAGE. NO A17 ALARMS WERE NOTED. UNIT RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS. UNIT RECEIVED WITH MINOR SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    A DIABETES EDUCATOR REPORTED THAT THE INSULIN PUMP WOULD COUNTDOWN AND RETURN AN ERROR ALARM. CALLER ALSO REPORTED THAT THE INSULIN PUMP RETURNED SEVERAL OTHER ALARMS. BLOOD GLUCOSE LEVEL WAS 222 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628674 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR