BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4813540 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-61720
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 12, 2015
    Report Date
    October 15, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED STUCK IN THE MOTOR ERROR ALARM LOOP DURING BOLUS AND BASAL DELIVERY ALSO, UNABLE TO CONFIRM EXCESSIVE NO DELIVERY ALARM DUE TO MOTOR ERROR ALARM. 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. UNABLE TO PERFORM EXCESSIVE NO DELIVERY TEST, A21 ERROR TEST AND OCCLUSION TEST DUE TO MOTOR ERROR ALARMS. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION AND PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST AND PRIME TEST. THE INSULIN PUMP HAD CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNER, BROKEN BELT CLIP SLOT, CRACKED DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, CRACKED CASE, SCRATCHED RESERVOIR TUBE WINDOW AND MISSING THE END CAP STICKER.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY EXCESSIVELY. THE NO DELIVERY ALARM WAS NOT CLEARED AFTER THE TUBING, RESERVOIR, AND SITE WERE CHANGED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356870 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715NAL

    Patients

    Seq Age Sex Outcome Treatment
    1