BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4160227 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25938
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAS EXPERIENCED NO INSULIN DELIVERY. CUSTOMER HAS PROBLEMS WITH THE INFUSION SETS. IT WAS STATED THAT THE CUSTOMER RECEIVED 3 BOXES WITH THE SAME LOT AND THERE WERE 5 FAULTY SECOND BOXES. CUSTOMER WAS INSTRUCTED TO GET IN CONTACT WHEN THE NO DELIVERY ALARM OCCURS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581332 PARADIGM INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715WWS

    Patients

    Seq Age Sex Outcome Treatment
    1