BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4103097 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26407
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    November 26, 2012
    Report Date
    August 26, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INSULIN PUMP WAS RECEIVED WITH NORMAL OPERATING CURRENTS. NO UNEXPECTED OFF NO POWER ALARM OR BLANK DISPLAY NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP WOULD NOT TURN ON. THE ISSUE WAS NOT RESOLVED WITH A BATTERY CHANGE. THE BLOOD GLUCOSE READING WAS NOT GIVEN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582661 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1