BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3820323 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-84822
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    UNABLE TO PRIME DURING THE PRIME TEST AND INSULIN PUMP ALARMED MOTOR ERROR DURING THE BASIC OCCLUSION TEST DUE TO A FAULTY FORCE SENSOR RESISTOR. UNABLE TO PERFORM THE OCCLUSION AND EXCESSIVE NO DELIVERY TESTS DUE TO THE PRIME/FILL ANOMALY. THE DEVICE PASSED THE SELF TEST, DISPLACEMENT AND MOTOR TESTS. A SCRATCHED DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP AND MISSING END CAP STICKER NOTED.

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. 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 CUSTOMER INSERTED THE INFUSION SET IN THE ABDOMEN. THE BLOOD GLUCOSE READING WAS 26.1MMOL/L, AND THE CUSTOMER ATE AND DELIVERED 13.0 UNITS. THE GLUCOSE LEVEL DROPPED TO 21.3MMOL/L, AND THEN IT WENT UP TO 22.1MMOL/L. THE CUSTOMER BOLUSED AGAIN AND THE GLUCOSE LEVEL DROPPED TO 20.3MMOL/L. THE CUSTOMER DID BOLUS AGAIN, BUT THE GLUCOSE LEVEL KEPT RISING. THE CUSTOMER DID NOT CHANGE THE INFUSION SET AT THIS TIME. THE CUSTOMER MENTIONED BEING HOSPITALIZED. THE DOCTOR REMOVED THE CANNULA AND IT WAS BENT, BUT THE DEVICE DID NOT ALARM NO DELIVERY AT THIS TIME, ONLY ALARMED MOTOR ERROR. THE CALLER STATED THAT THE INSULIN PUMP WAS EXPOSED TO X-RAYS IN APRIL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299876 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWS

    Patients

    Seq Age Sex Outcome Treatment
    1