BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4231300 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48479
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED MOTOR ERROR DURING REWIND DUE TO CORRODED MOTOR ASSEMBLY. THE INSULIN PUMP WAS UNABLE TO PERFORM BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST DUE TO MOTOR ANOMALY. THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. THE INSULIN PUMP WAS RECEIVED MISSING END CAP STICKER, CRACKED CASE AT DISPLAY WINDOW CORNERS, CASE AT RESERVOIR TUBE WINDOW CORNERS, BATTERY TUBE THREADS, BROKEN RESERVOIR TUBE LIP AND MINOR SCRATCHES ON LCD WINDOW.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A MOTOR ERROR ALARM, AND THE KEYPAD IS UNRESPONSIVE. THE CUSTOMER WAS UNABLE TO COMPLETE THE REWIND SEQUENCE. THE CUSTOMER'S BLOOD GLUCOSE WAS 273 MG/DL. NO SIGNIFICANT EVENTS LEADING TO THE ALARM WERE OBSERVED. ADVISED DISCONTINUATION OF THE INSULIN PUMP. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714420 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR