BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2083271 · Received April 13, 2011

    Report

    Report Number
    3004209178-2011-81050
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    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 WAS DELIVERING THE WRONG AMOUNT OF INSULIN. THE CUSTOMER STATED THAT HE HAS BEEN EXPERIENCING UNEXPLAINED HIGH BLOOD GLUCOSE LEVELS ON THE THIRD DAY OF WEARING HIS INFUSION SET AND RESERVOIR. THE CUSTOMER STATED THAT HE NOTICES THAT THE INSULIN PUMP IS NOT DELIVERING THE RIGHT AMOUNT OF INSULIN WHEN THE INSULIN REACHES THE SECOND BAR FROM THE TOP OF THE RESERVOIR AND THAT THIS HAS HAPPENED WITH HIS LAST THREE INFUSION SETS. THE CUSTOMER ALSO STATED THAT HE LAST CHANGED HIS INFUSION SET THE MORNING OF THE EVENT AND THAT HE USES A MODEL MMT-396 QUICK-SET INFUSION SET. TROUBLESHOOTING WAS PERFORMED AND THE INFUSION SET PASSED THE FIXED PRIME. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR UNOMEDICAL QUICK-SET INSULIN INFUSION SET:| MODEL MMT-396