BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4110694 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27468
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER'S BLOOD GLUCOSE WAS 102 MG/DL. THE CALLER STATED THAT THE INFUSION SET WAS CHANGED THE DAY PRIOR TO THE PHONE CALL, AND THERE WAS A HUGE WARM, HARD BALL AT THE SITE OF THE INSERTION. COLD COMPRESSES WERE APPLIED. IN THE MORNING OF THE PHONE CALL THE ALARM OCCURRED, WHILE THE CUSTOMER WAS SLEEPING. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS IN A BAG, AND THE CUSTOMER MIGHT HAVE SLEPT ON THE DEVICE, OR MIGHT HAVE URINATED ON IT A COUPLE OF NIGHTS AGO. THE CALLER STATED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS ELEVATED AND THEY WERE NOT SURE; THE INFUSION SET INSERTION SITE MIGHT BE INFECTED. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589411 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR