BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3892332 · Received June 24, 2014

    Report

    Report Number
    2032227-2014-03320
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 27, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED AFTER FOLLOW UP REPORT WAS SUBMITTED. THE INFORMATION HAS BEEN PROVIDED WITH THIS REPORT. THE INSULIN PUMP PASSED THE DELIVERY VOLUME ACCURACY TEST.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED FUNCTIONAL TESTING INCLUDING DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, NO DELIVERY AND OCCLUSION TESTS. DISPLAY WINDOW WAS SCRATCHED. INSULIN PUMP WAS PROGRAMMED WITH MULTIPLE BOLUSES AND MONITORED. THE UNITS LEFT IN THE STATUS SCREEN MATCHED THE UNITS LEFT IN THE RESERVOIR.

    Description of Event or Problem · 1

    THE CUSTOMER'S SPOUSE REPORTED LOW BLOOD GLUCOSE OF 23 MG/DL WHICH WAS TREATED WITH GLUCOSE TABLETS. THE CUSTOMER HAD LOW BLOOD GLUCOSE FOR SIX WEEKS AND TREATED WITH GLUCOSE SHOTS. TROUBLESHOOTING WAS PERFORMED AND THE DRIVE SUPPORT CAP APPEARED NORMAL, THE RESERVOIR SHOWED LESS INSULIN THAN WHAT WAS SHOWN ON THE STATUS SCREEN OF THE INSULIN PUMP. THE DISPLACEMENT TEST FAILED. THE CALLER STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO AN MRI. THE CALLER WAS ADVISED THAT THE INSULIN PUMP NEEDS TO BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367583 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR