BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4141789 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33585
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT THE CUSTOMER HAD RECEIVED REPEATED NO DELIVERY ALARMS ON THE INSULIN PUMP THROUGH THE NIGHT. CUSTOMER WANTED A NEW PUMP IMMEDIATELY. CUSTOMER STATED THAT THE PROBLEMS STARTED DURING BASAL DELIVERY. CUSTOMER DISCONNECTED AT THE QUICKRELEASE AND 5U FIXED PRIME DELIVERED, BUT PUMP DID NOT DELIVER INSULIN AND DID NOT ALARM NO DELIVERY. CUSTOMER WAS ASKED TO DO A MANUAL PLUNGER PUSH, BUT CUSTOMER DID NOT WISH TO DO SO. CUSTOMER STATED THAT SHE WOULD HAVE HER MOTHER CALL AND THEN CUSTOMER HUNG UP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621675 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1