BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3930556 · Received July 12, 2014

    Report

    Report Number
    3004209178-2014-86713
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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 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.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER'S INSULIN PUMP IS ALARMING MOTOR ERROR. THERE WAS A NO DELIVERY ALARM PRIOR TO THE MOTOR ERROR ALARM. MOTOR ERROR ALARM OCCURRED DURING BOLUS. THERE WERE NO SIGNIFICANT EVENTS LEADING UP TO THE ALARM, BUT CUSTOMER STATED THEY HAVE BEEN HAVING HIGHER BLOOD GLUCOSE LEVELS AND IS WORRIED ABOUT DELIVERY ANOMALIES. THE DEVICE WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD. THE ALARM WAS CLEARED. CUSTOMER SAID HE WAS ABLE TO REWIND THE DEVICE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. THE DEVICE WILL BE REPLACED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 13.7 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408804 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522WWB

    Patients

    Seq Age Sex Outcome Treatment
    1