BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3192666 · Received June 27, 2013

    Report

    Report Number
    2032227-2013-02589
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    PATIENT

    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

    THE INSULIN PUMP RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATION. THE INSULIN PUMP PASSED SELF TEST, ERROR TEST AND DISPLACEMENT TEST. UNABLE TO PRIME THE INSULIN PUMP DURING THE PRIME TEST AND MOTOR ERROR ALARMS DURING BASIC OCCLUSION TEST DUE TO FAULTY FORCE SENSOR. UNABLE TO PERFORM OCCLUSION TEST OR EXCESSIVE NO DELIVERY TEST DUE TO PRIME ANOMALY. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. THE DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH A SCRATCH LCD WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE INSULIN PUMP GAVE SEVERAL MOTOR ERROR ALARMS. THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE DISPLACEMENT AND SELF TESTS. THE CUSTOMER INSPECTED THE DRIVE SUPPORT CAP, AND HE STATED IT WAS NOT FLUSH OR PROTRUDED, BUT IT WAS SLIGHTLY UNEVEN. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED TO BE ON THE SAFE SIDE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294645 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR