BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4132027 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-30915
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    August 31, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A NO DELIVERY ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 467 MG/DL. THE CUSTOMER INSISTED ON PERFORMING A 5 UNITS BOLUS DELIVERY. THE CUSTOMER ALSO BELIEVED THE NO DELIVERY ALARM WAS DUE TO A SITE ISSUE. CUSTOMER WAS ADVISED HE MAY HAVE A BENT CANNULA OR A OCCLUDED SITE/SET. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611234 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR