BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2020489 · Received February 16, 2011

    Report

    Report Number
    3004209178-2011-80439
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 5, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 THAT THE INSULIN PUMP WAS DELIVERING INSULIN WITHOUT HIM BEING AWARE OF IT, AND THE DEVICE WAS NOT FUNCTIONING PROPERLY. THE CUSTOMER STATED THAT HE HAD EXPERIENCED A LOW BLOOD GLUCOSE EPISODE THREE DAYS AGO. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE HAD DROPPED AS LOW S 36MG/DL, BUT HIS GLUCOSE READING WAS 104MG/DL AT TIME OF CALL. ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE REMAINING INFUSION SET OF LOT 8. TROUBLESHOOTING WAS PERFORMED. ALL THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. REVIEWED THE STATUS SCREEN AND FOUND THAT THERE WAS LESS INSULIN IN THE RESERVOIR THAN WHAT THE STATUS SCREEN INDICATED. RAN A DISPLACEMENT TEST AND THE DEVICE PASSED THE TEST. NO FURTHER INFORMATION WAS PROVIDED.

    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 20 YR