BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PU,P

    MDR report key: 4208730 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30051
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IS IT 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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A NO DELIVERY ALARM. CUSTOMER'S BLOOD GLUCOSE WAS OVER 200 MG/DL. THE CUSTOMER STATED THE ALARM WAS RESOLVED BY A COMPLETE INFUSION SET CHANGE. THE CUSTOMER ALSO REPORTED RECEIVING THE ALARM A COUPLE MONTHS AGO. THE ALARM WAS ALSO RESOLVED WITH A COMPLETE INFUSION SET CHANGE. THE CUSTOMER DECLINED TO RETURN THE INFUSION SET AND INSULIN PUMP FOR ANALYSIS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603875 530G INSULIN PU,P OZO MEDTRONIC MINIMED MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR