BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 3831255 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-84944
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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

    CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE READING WAS NOT PROVIDED AT THAT TIME OF CALL. THE CUSTOMER STATED THAT SHE WAS EXPERIENCING A NO DELIVERY ALARM WHILE PRIMING. ASSISTED THE CUSTOMER WITH THE CONNECTION PROCESS OF THE TUBING AND THE RESERVOIR. ADVISED CUSTOMER TO REPLACE THE PLUNGER. NO OTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308507 MODEL NOT SPECIFIED INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization