BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3953962 · Received July 23, 2014

    Report

    Report Number
    2032227-2014-04774
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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

    CUSTOMER REPORTED THE INSULIN PUMP ALARMED DURING THE MANUAL PRIME. TROUBLESHOOTING WAS PERFORMED. CUSTOMER'S BLOOD GLUCOSE WAS 124 MG/DL. CUSTOMER REPORTED THE INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME. CUSTOMER STATED THE DEVICE WAS NOT DROPPED OR BUMPED. CUSTOMER WAS ADVISED TO REMAIN DISCONNECTED. CUSTOMER REPORTED THE DEVICE SUPPORT CAP WAS STICKING OUT. CUSTOMER DID NOT PUSH IN THE CAP. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACK UP PLAN. CUSTOMER WAS ADVISED THE DEVICE NEED TO BE REPLACED. CUSTOMER DECLINED TO SURRENDER THE DEVICE TO MEDTRONIC FOR FAILURE ANALYSIS. CUSTOMER HAD ANOTHER INSULIN PUMP. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431346 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR