BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3093681 · Received May 6, 2013

    Report

    Report Number
    2032227-2013-01662
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH PROTRUDED/LOOSE DRIVE SUPPORT DISK, BROKEN RESERVOIR TUBE LIP, MISSING END CAP STICKER AND BROKEN BATTERY CAP.

    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

    CUSTOMER'S MOTHER CALLED RESPONDING TO THE FIELD NOTIFICATION LETTER. CALLER STATED THAT HER DAUGHTER'S DRIVE SUPPORT CAP IS STICKING OUT. CUSTOMER'S BLOOD GLUCOSE READING IS 210 MG/DL. CUSTOMER IS SICK AT THIS TIME. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196101 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR