BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4143721 · Received October 6, 2014

    Report

    Report Number
    2032227-2014-32018
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE LIP, CRACKED BELT CLIP SLOT, AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE IS A CRACK IN THE INSULIN PUMP'S CASE. THE CUSTOMER ALSO REPORTED THAT THE DRIVE SUPPORT CAP APPEARS TO BE DAMAGED. THE BLOOD GLUCOSE LEVEL WAS NOT INCLUDED IN THE REPORT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623649 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722WWP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other