BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 6166788 · Received December 12, 2016

    Report

    Report Number
    2032227-2016-49441
    Event Type
    Injury
    Date Received
    December 12, 2016
    Date of Event
    May 12, 2016
    Report Date
    November 16, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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

    CUSTOMER REPORTED VIA PHONE CALL TO HAVE BEEN HOSPITALIZED ON (B)(6) 2016 WITH BLOOD GLUCOSE OF 850 MG/DL. CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS AND TREATED AT THE HOSPITAL. CUSTOMER WAS WEARING INSULIN PUMP AT THE TIME OF HOSPITALIZATION. CUSTOMER DECLINED TO TROUBLESHOOT. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817989 530G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| O