BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4122534 · Received September 18, 2014

    Report

    Report Number
    2032227-2014-24548
    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
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY ALARM AND DISPLACEMENT TESTS. NO ALARM WAS NOTED FOR A LOOSE DRIVE SUPPORT DISK. HOWEVER, THE DRIVE SUPPORT WAS FOUND LOOSE AND TILTED. THE INSULIN PUMP WAS RECEIVED WITH A BROKEN BATTERY CAP, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Additional Manufacturer Narrative · 1

    (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 UNITED STATES. CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO 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 INSULIN PUMP ALARMED DURING THE MANUAL PRIME. CUSTOMER STATED THAT THE PISTON CONTINUES TO MOVE FORWARD AFTER RESERVOIR CONTACT AND INSULIN WAS SQUIRTING OUT. THE DRIVE SUPPORT CAP WAS NOTED TO BE LOOSE. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 107 MG/DL. NO FURTHER INFO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579393 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-754WWL

    Patients

    Seq Age Sex Outcome Treatment
    1