BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2003060 · Received February 8, 2011

    Report

    Report Number
    3004209178-2011-80365
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE. THE MOTHER STATED THAT THEY NOTICED THE PISTON ON THE INSULIN PUMP WAS NOT HITTING THE BACK OF THE RESERVOIR, WHICH CAUSED TO RISE THE CUSTOMER'S BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE CUSTOMER WAS ON MULTIPLE DAILY INSULIN. RAN A FIXED PRIME AND A DETACHMENT TEST AND THE INSULIN DEVICE PASSED THE TESTS. PERFORMED HIGH PRESSURE TEST TWICE AND THE INSULIN PUMP FAILED THE TEST. NO FURTHER INFO 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-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR