BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2220065 · Received August 12, 2011

    Report

    Report Number
    3004209178-2011-82529
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 19, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 BELIEVES THAT THE NO DELIVERY ALARM WAS NOT FUNCTIONING PROPERLY. THE CUSTOMER ALSO REPORTED HAVING LOW RESERVOIR ALARMS, AND THEN SHE RECEIVED NO DELIVERY ALARM. IT WAS STATED THAT A TUBING CLAMP WAS NOT AVAILABLE AND THE HIGH PRESSURE WAS NOT PERFORMED AT TIME OF CALL. ADVISED THE CUSTOMER TO CHANGE THE RESERVOIR IMMEDIATELY AFTER GETTING A LOW RESERVOIR ALARM. NO FURTHER INFO WAS PERFORMED.

    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 59 YR