BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4050359 · Received September 1, 2014

    Report

    Report Number
    2032227-2014-15172
    Event Type
    Malfunction
    Date Received
    September 1, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST AND ALARMED FOR A MOTOR ERROR DURING THE BASIC OCCLUSION TEST DUE TO A PROTRUDED AND LOOSE DRIVE SUPPORT DISK. NO ALARM WAS NOTED FOR THE LOOSE DRIVE SUPPORT DISK. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED THE MOTOR TEST. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS, A BROKEN BELT CLIP SLOT AND A CRACKED RESERVOIR TUBE LIP.

    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 CUSTOMER'S INSULIN PUMP HAD A PRIME ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 100 MG/DL. THE DRIVE SUPPORT CAP IS STICKING OUT. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531861 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754WWP

    Patients

    Seq Age Sex Outcome Treatment
    1