BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4150397 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-35094
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED BASIC OCCLUSION TEST AND DISPLACEMENT TEST. NO MOTOR ERROR ALARMS WERE NOTED. HOWEVER, THE DEVICE WAS UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR RESISTOR. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND IT PASSED. THE DEVICE HAD CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, AND MINOR SCRATCHED DISPLAY WINDOW.

    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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING BOLUS/BASAL DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE ALARM HAD OCCURRED NINE TIMES WITHIN THIRTY DAYS. THE CUSTOMER DOES NOT USE THE SENSOR FEATURE. THEY WERE ABLE TO COMPLETE THE REWIND SEQUENCE. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628273 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1