BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4153732 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-24910
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.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'S BLOOD GLUCOSE WAS 33.4 MMOL/L, WHICH WAS TREATED WITH MANUAL INJECTION. TROUBLESHOOTING WAS PERFORMED WITH THE INSULIN PUMP. IT WAS STATED THAT BLEEDING AT THE SITE HAD CEASED. DURING THE FILL TUBING PROCESS, THE CUSTOMER HEARD A TAPERED TONE AT THE END AND INSULIN EXITED THE TUBING. THE PROGRAMMING AND SETTINGS APPEARED TO BE FINE. NO ANOMALIES WERE FOUND IN THE INSULIN PUMP HISTORY. THE HIGH PRESSURE TEST WAS PERFORMED AND PASSED. INSULIN EXITED THE TUBING DURING A 5 UNIT PRIME. THERE WAS NO RESISTANCE WHEN A PLUNGER WAS USED WITH THE RESERVOIR. THE CUSTOMER WAS INSERTING ON THE FRONT OF HIS LEG. OTHER INSERTION SITES WERE RECOMMENDED WITH THE INFUSION SET, AS WELL AS USE OF A SHORTER CANNULA. THE CUSTOMER INSERTED A NEW SET ON HIS ABDOMEN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632136 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CML

    Patients

    Seq Age Sex Outcome Treatment
    1