BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4152160 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-34568
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    August 31, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH VIBRATOR RATTLING DUE TO VIBRATOR ADHESIVE NOT ADHERING. THE DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED. THE INSULIN PUMP HAS CRACKED CASE AT DISPLAY WINDOW CORNER, BATTERY TUBE THREADS, RESERVOIR TUBE LIP, BELT CLIP SLOT AND MINOR SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A CUSTOMER STATED THAT THE DRIVE SUPPORT CAP ON THEIR INSULIN PUMP IS DAMAGED. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS NOT RECORDED. THE CUSTOMER STATED THAT THERE WERE NO SIGNIFICANT EVENTS THAT COULD HAVE LED TO THE ISSUE. THE CUSTOMER WAS INFORMED THAT THE PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630944 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CAP

    Patients

    Seq Age Sex Outcome Treatment
    1