BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3900924 · Received June 27, 2014

    Report

    Report Number
    2032227-2014-03400
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    March 20, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH ALARMS DURING BASIC OCCLUSION TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNIT RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, RESERVOIR TUBE LIP AND SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE HAD HIGH BLOOD GLUCOSE OF 516 MG/DL AND THE INSULIN PUMP WAS NOT WORKING CORRECTLY. CUSTOMER STATED THAT THE INSULIN PUMP WAS ALARMING AND SQUIRTING THE INSULIN OUT DURING PRIME REWIND PROCESS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376928 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR