BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530 G INSULIN PUMP

    MDR report key: 4143417 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30048
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 29, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC (B)(4).

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED COMMUNICATION ISSUES BETWEEN THE INSULIN PUMP AND SENSOR. THE MOTHER ALSO REPORTED THAT THE CUSTOMER WAS HAVING A LOW BLOOD GLUCOSE OF 40 MG/DL. THE MOTHER STATED THE CUSTOMER TREATED HIS BLOOD GLUCOSE WITH FOOD. THE MOTHER ALSO DECLINED TO TROUBLESHOOT. NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603438 530 G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR