BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2170667 · Received July 12, 2011

    Report

    Report Number
    3004209178-2011-82163
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 GOING TO THE HOSPITAL DUE TO HIGH BLOOD GLUCOSE. IT WAS STATED THAT THERE WERE ANOMALIES WITH THE TEMPORARY BASAL FUNCTION ON THE CUSTOMER'S INSULIN PUMP. IT WAS STATED THAT THE CUSTOMER WAS EXPERIENCING HIGH GLUCOSE FOR THE (B)(6), AND THE TEMPORARY BASALS WERE SET TO 150% AND THEN TO 190%. IT WAS STATED THAT UPON DOWNLOADING THE INSULIN PUMP, THE TEMPORARY BASAL FUNCTION HAD BEEN SWITCHING BETWEEN THESE SETTINGS AND DROPPED DOWN. IT WAS STATED THAT UPON LOOKING AT THE DOWNLOAD, IT WAS NOTICED THAT THE CHANGES HAPPENED IN A SHORT PERIOD OF TIME. 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-722WWB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization