BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3844209 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-84770
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING BASIC OCCLUSION TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, CRACKED BELT CLIP SLOT AND MISSING END CAP STICKER.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED DURING THE PRIME PROCESS. THE DRIVE SUPPORT CAP IS LOOSE. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322036 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715WWP

    Patients

    Seq Age Sex Outcome Treatment
    1