BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2923176 · Received January 18, 2013

    Report

    Report Number
    2032227-2013-00259
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD A FROZEN DISPLAY AND CONSTANT TONE DUE TO CORROSION ON THE MOTHER BOARD. THE INSULIN PUMP HAD A CRACKED DISPLAY WINDOW AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CRACK ON THE CASE, NEAR THE RESERVOIR AND BATTERY COMPARTMENTS. THE CUSTOMER ALSO REPORTED FLUID INSIDE THE CASE DUE TO GOING INTO THE POOL WITH THE INSULIN PUMP ON. THE CUSTOMER STATED THAT SHE REMOVED THE BATTERY AND INSERTED A NEW ONE. THE CUSTOMER STATED THE INSULIN PUMP COUNTED UP TO THE NUMBER 6, THEN FROZE. PRIOR TO GOING INTO THE POOL, THE CUSTOMER HAD RECEIVED TWO ALARMS WITH A LOUD BEEP. 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
    27804 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR