BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4233808 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48872
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST AND PRIME TEST. INSULIN PUMP RECEIVED STUCK IN MOTOR ERROR LOOP DURING BOLUS AND BASAL DELIVERY. NO ALARM NOTED IN ALARM HISTORY SCREEN. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING. INSULIN PUMP WAS UNABLE TO PERFORM THE OCCLUSION TEST AND EXCESSIVE NO DELIVERY TEST DUE TO MOTOR ERROR ALARM. INSULIN PUMP HAD A CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON LCD WINDOW, CRACKED CASE AT WINDOW DISPLAY CORNER AND SCRATCHED RESERVOIR TUBE WINDOW.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. CUSTOMER STATED HE WAS PRIMING THE INSULIN PUMP, IT STARTED COUNTING DOWN AND RESET ITSELF. CUSTOMER PROGRAMMED IT AND THEN ATTEMPTED TO DELIVER A BOLUS AND A SECOND MOTOR ERROR ALARM OCCURRED. DEVICE WAS NOT EXPOSED TO A MAGNETIC FIELD. CUSTOMER DOES NOT USE THE SENSOR FEATURE AND IS UNABLE TO COMPLETE THE REWIND SEQUENCE. CUSTOMER REPORTED THAT HE RECEIVED A MOTOR POSITION ENCODER ERROR ALARM. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714793 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR