BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4923227 · Received July 17, 2015

    Report

    Report Number
    2032227-2015-22472
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    June 26, 2015
    Report Date
    June 26, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    K053177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED AND REPORTED THE INSULIN PUMP ALARMED TO INDICATE THE FORCE SENSOR SYSTEM WAS COMPROMISED. THE CUSTOMER'S BLOOD GLUCOSE WAS REPORTEDLY WITHIN NORMAL RANGE. THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR ANALYSIS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466884 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-712EWS

    Patients

    Seq Age Sex Outcome Treatment
    1