BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 6155171 · Received December 8, 2016

    Report

    Report Number
    2032227-2016-48397
    Event Type
    Injury
    Date Received
    December 8, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 11, 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 THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS DUE TO HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE WAS CLOSE TO 600 MG/DL. CUSTOMER WAS WEARING THE DEVICE AT TIME OF HOSPITALIZATION. DURING TROUBLESHOOTING, DEVICE PASSED THE HIGH PRESSURE TEST. AFTER TROUBLESHOOTING, CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804931 530G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551PNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization