BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3081258 · Received April 26, 2013

    Report

    Report Number
    2032227-2013-01541
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    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. 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

    THE CUSTOMER REPORTED A PROTRUDING DRIVE SUPPORT CAP AND A CRACK ON THE CASE. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD BEEN BUMPED SEVERAL TIMES WHILE HE PLAYS GOLF. THE CUSTOMER HAS BEEN PUSHING THE CAP BACK IN PLACE, AND HAS NOT HAD ANY PROBLEMS. THE CUSTOMER STATED THAT HE SOMETIMES GETS NO DELIVERY ALARMS. ADVISED THE CUSTOMER THAT THE INSULIN PUMP SHOULD BE REPLACED, BUT HE DECLINED. HE STATED HE WILL CALL US IF HE WANTS IT REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182898 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR