BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4103782 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26676
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    June 16, 2014
    Report Date
    August 26, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP WAS DAMAGED BUT THAT THE INFUSION SET AND RESERVOIR DID NOT SHOW ANY SIGNS OF DAMAGE. THE BLOOD GLUCOSE READING WAS 201 MG/DL. HE REPORTED DEEP SCRATCHES IN THE DISPLAY SCREEN. HE STATED THAT THE DAMAGE OCCURRED DUE TO NORMAL WEAR AND TEAR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585281 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR