BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3895508 · Received June 25, 2014

    Report

    Report Number
    3004209178-2014-86145
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 22, 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

    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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH CRACKED END CAP, MISSING END CAP STICKER, MINOR SCRATCHES ON LCD WINDOW, CRACKED RESERVOIR TUBE AND CRACKED BATTERY TUBE THREADS. NO LOOSE DRIVE SUPPORT DISK NOTED.

    Description of Event or Problem · 1

    CUSTOMER IS EXPERIENCING HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING IS 230 MG/DL. THE DRIVE SUPPORT CAP IS LOOSE. THE INSULIN PUMP WAS HIT AGAINST THE WASHING MACHINE. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370230 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715WWS

    Patients

    Seq Age Sex Outcome Treatment
    1