BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 5435123 · Received February 12, 2016

    Report

    Report Number
    3004209178-2016-86802
    Event Type
    Malfunction
    Date Received
    February 12, 2016
    Date of Event
    January 29, 2016
    Report Date
    January 29, 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THE INSULIN PUMP ALARM PRIME REWIND. CUSTOMER'S BLOOD GLUCOSE AT TIME OF INCIDENT WAS 108 MG/DL. THE CUSTOMER STATED THEY ARE RECEIVING A COMPROMISED FORCE SENSOR ALARM. THE CUSTOMER STATED THAT THE DEVICE WAS NOT DROPPED OR BUMPED. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP IS FLUSH WITH THE CASING. THE CUSTOMER DOES NOT RECALL PRESSING THE CAP WHILE CONNECTED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER INSULIN PUMP IS OOW AND WE SHALL SEND HER THE OOW LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92251 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715WWL

    Patients

    Seq Age Sex Outcome Treatment
    1