BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4233549 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48742
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 25, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PATIENT

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(2).

    Additional Manufacturer Narrative · 1

    NO MOTOR ERROR ALARM NOTED. THE INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST DUE TO MOISTURE DAMAGE ON FORCE SENSOR. THE INSULIN PUMP WAS UNABLE TO PERFORM EXCESSIVE NO DELIVERY TEST AND OCCLUSION TEST DUE TO PRIME/FILL ANOMALY. THE MOTOR WAS TESTED OUTSIDE THE INSULIN PUMP AND PASSED. THE INSULIN PUMP HAD A CRACKED RESERVOIR TUBE, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED BELT CLIP SLOT, BROKEN BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND MINOR SCRATCHES ON LCD WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ISSUES WITH THE INSULIN PUMP. CUSTOMER STATES THAT THERE IS A MOTOR ERROR ALARM. THE BLOOD GLUCOSE READING IS BETWEEN 160-200 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714697 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR