BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4150015 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-34903
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON THE DISPLAY WINDOW, A MISSING END CAP STICKER AND A CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS WERE NOTED DURING THE VISUAL INSPECTION. THE INSULIN PUMP PASSED THE PRIME, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TESTS. NO MOTOR ERROR ALARM WAS NOTED. THE MOTOR TESTED OKAY.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 DURING EITHER A BOLUS OR BASAL DELIVERY ATTEMPT. THERE WERE MULTIPLE ALARMS IN THE INSULIN PUMP HISTORY. THE CUSTOMER'S BLOOD GLUCOSE WAS NOT KNOWN. THE INSULIN PUMP WAS REPORTEDLY NOT EXPOSED TO A STRONG MAGNETIC FIELD. IT WAS STATED THAT THE CUSTOMER WAS NOT USING THE SENSOR FEATURE ON THE INSULIN PUMP. THE CUSTOMER WAS REPORTEDLY ABLE TO REWIND THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627974 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554WWS

    Patients

    Seq Age Sex Outcome Treatment
    1