BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530 G INSULIN PUMP

    MDR report key: 4143399 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30046
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK 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 BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE. THE CUSTOMER ALSO REPORTED HAVING DIABETES KETOACIDOSIS. DATE OF HOSPITALIZATION WAS (B)(6) 2014. BLOOD GLUCOSE AT THE TIME OF ADMISSION WAS 675 MG/DL. THE CUSTOMER REPORTED THAT HE HAD ATTEMPTED TO BOLUS FOR A BLOOD GLUCOSE OF 491 MG/DL WHEN HE RECEIVED A NO DELIVERY ALARM. THE CUSTOMER STATED HE FELT NAUSEOUS AND FATIGUED SHORTLY AFTER RECEIVING THE NO DELIVERY ALARM. THE CUSTOMER STATED HE WAS BEING TREATED WITH AN INSULIN DRIP AT THE HOSP. NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603316 530 G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization