BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIM INSULIN INFUSION PUMP

    MDR report key: 4122877 · Received September 18, 2014

    Report

    Report Number
    2032227-2014-24796
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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

    THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY ALARM TESTS. NO MOTOR ERROR ALARM WAS NOTED. THE MOTOR PASSED THE MOTOR TEST. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, A CRACKED CASE AT A DISPLAY WINDOW CORNER, MINOR SCRATCHES ON THE DISPLAY WINDOW, SCRATCHED RESERVOIR TUBE WINDOW, AND A BROKEN BELT CLIP SLOT.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4). 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 UNITES STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING BOLUS/BASAL DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE WAS 125 MG/DL. THE CUSTOMER DOES NOT USE THE SENSOR FEATURE. THEY WERE ABLE TO REWIND THE DEVICE. THE ALARM HAD OCCURRED ONLY ONCE WITHIN THIRTY DAYS. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578925 PARADIGM REAL-TIM INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-754WWP

    Patients

    Seq Age Sex Outcome Treatment
    1