BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4292163 · Received December 2, 2014

    Report

    Report Number
    2032227-2014-60845
    Event Type
    Malfunction
    Date Received
    December 2, 2014
    Date of Event
    November 3, 2014
    Report Date
    November 3, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    A DOCTOR REPORTED THAT THE INSULIN PUMP IS STUCK DURING THE REWIND STAGE. THE DOCTOR STATED HE IS USING THE INSULIN PUMP TO DISPERSE PAIN MEDICATIONS FOR A PATIENT, WHICH IS OFF LABEL USE. THE DOCTOR AND HIS PATIENT ARE NOT MEDTRONIC CUSTOMERS. THE CALL WAS DISCONNECTED. THERE WAS NO NUMBER AVAILABLE FOR A CALL BACK. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776761 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1