BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4090470 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-19857
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH STUCK MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY. 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 THE A21 ERROR, OCCLUSION AND EXCESSIVE NO DELIVERY TESTS DUE TO MOTOR ERROR ALARM. HOWEVER, THE INSULIN PUMP PASSED REWIND, BASIC OCCLUSION, PRIME/A33 AND DISPLACEMENT TESTS. THE INSULIN PUMP WAS ALSO RECEIVED WITH CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, CASE CRACKED AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHED LCD WINDOW AND SCRATCHED RESERVOIR TUBE 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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A MOTOR ERROR ALARM ON THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS 130 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570287 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554WWL

    Patients

    Seq Age Sex Outcome Treatment
    1