BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4790665 · Received May 22, 2015

    Report

    Report Number
    3004209178-2015-58331
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    April 15, 2015
    Report Date
    May 1, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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. PLEASE SEE MEDWATCH REPORT # 2032227-2015-16394 REGARDING THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED AND REPORTED HE WAS HOSPITALIZED WITH AN ACUTE PANCREATIS ATTACK AND POSSIBLY DIABETIC KETOACIDOSIS. THE CUSTOMER STATED THE LAST BLOOD GLUCOSE READING HE REMEMBERED AT TIME OF THE ISSUE WAS AROUND 300 MG/DL, WHICH HE TREATED WITH THE INSULIN PUMP. CUSTOMER WAS ADMITTED TO THE HOSPITAL OVERNIGHT FOR TREATMENT OF PANCREAS PAIN AND HIGH BLOOD GLUCOSE VALUES. HE WAS WEARING THE INSULIN PUMP AT TIME OF THE EMERGENCY ROOM VISIT. THE CUSTOMER WAS ADVISED THE INSULIN PUMP WOULD BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335693 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization