BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3930504 · Received July 12, 2014

    Report

    Report Number
    2032227-2014-03616
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 28, 2014
    Report Date
    June 28, 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

    ALL OF THE BUTTONS ON THE INSULIN PUMP RESPONDED PROPERLY. NO BUTTON ANOMALIES WERE NOTED. HOWEVER, SLIGHT MOISTURE TRACES WERE FOUND AT KEYPAD TRACES. THE INSULIN PUMP HAD A CRACKED CASE AT DISPLAY WINDOW CORNERS AND BATTERY TUBE THREADS, AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    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 RETURN 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 CUSTOMER BLOOD GLUCOSE WAS 112 MG/DL. CALLER STATED THAT THE CUSTOMER'S INSULIN PUMP WAS NOT WORKING CORRECTLY. THE KEYPAD HAS ISSUES AND THE B BUTTON WAS NOT RESPONDING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408784 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LWWB

    Patients

    Seq Age Sex Outcome Treatment
    1