BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4160140 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26285
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP WAS GOING INTO LOW THRESHOLD SUSPEND BASED ON SENSOR READINGS, WHILE HIS BLOOD GLUCOSE IS HIGH. THE CUSTOMER HAD A BLOOD GLUCOSE OF 563 MG/DL WHEN HE RAN WITH A DOG, AND THIS WAS TREATED WITH MANUAL INJECTION. THE INSULIN PUMP WAS VERIFIED TO BE DELIVERING BY PUSHING INSULIN OUT OF THE CANNULA. AN INFUSION SET CHANGE WAS PERFORMED WHEN THE CUSTOMER'S BLOOD GLUCOSE WAS 569 MG/DL. TROUBLESHOOTING WAS NOT PERFORMED AND THE CUSTOMER'S BLOOD GLUCOSE WAS DOWN TO 305 MG/DL, WHICH IT WAS STATED, WOULD CONTINUE TO BE MONITORED EVERY 30 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581192 530G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR