BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3972064 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05053
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP PASSED THE BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. NO UNEXPECTED NO DELIVERY OR MOTOR ERROR ALARMS WERE NOTED. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. THE UNIT WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP AND MINOR SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED MOTOR ERROR AND NO DELIVERY ALARMS ON HER INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS 8.1 MMOL/L. THE NO DELIVERY ALARM WAS RESOLVED WITH A COMPLETE SET CHANGE. THE CUSTOMER WAS ABLE TO REWIND THE INSULIN PUMP, BUT WAS ADVISED TO DISCONTINUE USE AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448488 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554LWWH

    Patients

    Seq Age Sex Outcome Treatment
    1