BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4422437 · Received January 15, 2015

    Report

    Report Number
    2032227-2015-02117
    Event Type
    Malfunction
    Date Received
    January 15, 2015
    Date of Event
    March 22, 2011
    Report Date
    December 23, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP RECEIVED WITH CONSTANT SOFTWARE ERROR ALARM DUE TO POOR SOLDER JOINT AT U7 ON MB/B. PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHED LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW AND STAINED END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER RECEIVED A SOFTWARE ERROR ALARM. INSULIN PUMP WAS STORED WITHOUT BATTERIES. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36022 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512WWB

    Patients

    Seq Age Sex Outcome Treatment
    1