BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4103080 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26410
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    April 22, 2014
    Report Date
    August 26, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INSULIN PUMP FAILED THE DISPLACEMENT TEST (170.6 UNITS LEFT ON STATUS SCREEN) AND MOTOR ERROR ALARMS DURING REWIND DUE TO OUT OF PHASE MOTOR ENCODER SIGNAL. NO A35 ALARMS NOTED. CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON DISPLAY WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED.

    Description of Event or Problem · 1

    CUSTOMER'S HUSBAND REPORTED THAT THE CUSTOMER HAD A MRI AND THE INSULIN PUMP WAS NOT REMOVED. HE STATED THAT THE INSULIN PUMP ALARMED FOR A MOTOR ERROR. THE BLOOD GLUCOSE READING WAS 104 MG/DL. HE WAS ASSISTED IN CLEARING THE ALARM. HE STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. HE STATED THAT THEY WERE NOT ABLE TO REWIND THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582359 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR