BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 6028112 · Received October 13, 2016

    Report

    Report Number
    2032227-2016-31955
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 21, 2016
    Report Date
    September 21, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THE INSULIN PUMP ALARM COMPROMISED FORCE SENSOR OCCURRED DURING FILL TUBING. CUSTOMER'S BLOOD GLUCOSE AT TIME OF INCIDENT WAS 170 MG/DL. CUSTOMER WAS ADVISED TO REVERT TO BACKUP PLAN AND WE WILL SEND OOW LETTER, PUMP IS OOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677716 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715WWL

    Patients

    Seq Age Sex Outcome Treatment
    1