BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4153694 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-35426
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS TO HAVE RECEIVED EXCESSIVE NO DELIVERY ALARMS. CUSTOMER STATES THAT SHE WAS ADVISED TO REVERT TO BACK UP INSULIN PUMP AND A REQUEST FOR A NEW INSULIN PUMP WOULD BE PROCESSED. CUSTOMER WAS NOT ABLE TO TROUBLESHOOT DUE TO INSULIN PUMP ALREADY PACKAGED AND CUSTOMER NOT AVAILABLE AT THE TIME. CUSTOMER STATES ONCE SHE IS AVAILABLE TO TROUBLESHOOT, SHE WILL UNPACK INSULIN PUMP AND TROUBLESHOOT FOR NO DELIVERY ALARMS. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632202 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR