BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4082681 · Received September 11, 2014

    Report

    Report Number
    2032227-2014-21685
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    March 10, 2014
    Report Date
    August 14, 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

    THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE ON DISPLAY WINDOW CORNERS, MINOR SCRATCHED DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP, AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD A CRACK IN THE CASE. THE INSULIN PUMP HAD NOT BEEN DROPPED OR BUMPED. THE DRIVE SUPPORT CAP DID NOT APPEAR TO BE DAMAGED. THE BLOOD GLUCOSE READING WAS NOT GIVEN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562366 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1