BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4082676 · Received September 11, 2014

    Report

    Report Number
    2032227-2014-21505
    Event Type
    Injury
    Date Received
    September 11, 2014
    Date of Event
    August 11, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED A HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 363 MG/DL AT THE TIME OF THE REPORT. CUSTOMER TREATED WITH THE INSULIN PUMP. SHE STATED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE EVENT. SHE STATED THAT THE BASAL RATES WERE CORRECT. THE BLOOD GLUCOSE READING WHILE THE CUSTOMER WAS IN THE HOSPITAL WAS OVER 500 MG/DL AND CUSTOMER WAS TREATED WITH AN IV DRIP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561246 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization