BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4161993 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36076
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A NO DELIVERY ALARM ABOUT A WEEK AGO. CUSTOMER NEEDS TO HAVE HIS INSULIN PUMP REPLACED. CUSTOMER REPORTED THAT HE WAS UNABLE TO TROUBLESHOOT AT THE TIME OF THE CALL. CUSTOMER WAS UNABLE TO TROUBLESHOOT DUE TO IT BEING A PAST EVENT. CUSTOMER DOES NOT WANT TO RETURN THE SET AND RESERVOIR FOR ANALYSIS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643789 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722LNAS A2722LNASJ

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR