BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3970040 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88354
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    NO BUTTON ERROR ALARM OR UNEXPECTED AUDIO ANOMALY WAS NOTED. THE INSULIN PUMP HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO WEAK BATTERY ALARM COULD BE TESTED DUE TO THE UNRESPONSIVE BUTTONS. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE LIP AND A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THE DEVICE KEPT BEEPING AND IT WOULD NOT ALLOW THE CUSTOMER TO PRESS ANY BUTTONS OR CLEAR THE ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 9.1 MMOL/L. IT WAS REPORTED THAT PRIOR TO THE BUTTON ERROR ALARM THE INSULIN PUMP ALSO ALARMED WEAK BATTERY. THE CUSTOMER CHANGED THE BATTERY WHICH TRIGGERED THE BUTTON ERROR ALARM. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446598 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CAS

    Patients

    Seq Age Sex Outcome Treatment
    1