BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2253917 · Received September 13, 2011

    Report

    Report Number
    3004209178-2011-82906
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    August 28, 2011
    Report Date
    August 30, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING A BLANK DISPLAY. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HE CHANGED THE BATTERY AND THE DISPLAY RETURNED. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS STORED WITHOUT A BATTERY FOR AN EXTENDED PERIOD OF TIME. DURING THE CALL, THE CUSTOMER MENTIONED BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. THE CUSTOMER STATED THAT HIS LAST INFUSION SET CHANGE WAS MAY BE A WEEK AND A HALF AGO. INSTRUCTED TO THE CUSTOMER TO CHANGE OUT THE INFUSION SET EVERY TWO TO THREE DAYS. THE CUSTOMER ASSEMBLED A NEW INFUSION SET AND RESERVOIR TO RUN A FIXED TEST AND THE TEST PASSED. THE CUSTOMER STATED THAT THE INSULIN PUMP HAS A CRACK ACROSS THE FRONT PANEL. EXPLAINED TO CUSTOMER TO REVERT TO BACK UP PLAN. ADVISED THE CUSTOMER THAT A REPLACEMENT OF THE INSULIN PUMP WILL BE SENT. 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-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization UNOMEDICAL INFUSION SET, MMT-397| QUICK-SET, 23, PARADIGM, 9MM CATHETER