BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2191276 · Received July 28, 2011

    Report

    Report Number
    3004209178-2011-82334
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER STATED HE RECEIVED A MOTOR ERROR WHEN HE CALLED PREVIOUSLY. THE CUSTOMER STATED THAT IT APPEARED THE INSULIN PUMP WAS REWINDING PROPERLY. ADVISED CUSTOMER TO CHECK HIS BLOOD GLUCOSE AND FOUND THAT HIS GLUCOSE LEVEL WAS LOW. INSTRUCTED CUSTOMER TO RUN A DISPLACEMENT TEST AND THE INSULIN PUMP FAILED THE TEST. INSTRUCTED TO CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR PARADIGM 6MM CATHETER| QUICK-SET 23| UNOMEDICAL INFUSION SET: MMT-399