BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 6158354 · Received December 9, 2016

    Report

    Report Number
    2032227-2016-49099
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    November 13, 2016
    Report Date
    November 14, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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 THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS DUE TO HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE WAS 513 MG/DL. CUSTOMER WAS WEARING THE DEVICE AT TIME OF HOSPITALIZATION. AFTER TROUBLESHOOTING, CUSTOMER WAS ADVISED THAT A TUBING CLAMP WILL BE SENT TO PERFORM THE HIGH PRESSURE TEST. CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811524 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization