BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3864369 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-85536
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP WAS BEEPING AND IT WAS GIVING HER TOO MUCH INSULIN. THE CUSTOMER'S BLOOD GLUCOSE WAS 71, THEN WENT UP TO 90MG/DL AFTER EATING A MOON PIE AND DRINKING MILK. THE CALLER MENTIONED THAT THERE WERE AIR BUBBLES IN THE RESERVOIR AND THEY CHANGED THE ENTIRE INFUSION SET. THE CALLER STATED THAT THE DEVICE WAS SET TO VIBRATE NOT TO BEEP. TROUBLESHOOTING WAS PERFORMED, AND NO DAMAGE TO THE DRIVE SUPPORT CAP NOTED. THE SELF TEST WAS COMPLETED AND PASSED. THE CUSTOMER WAS NOT ADMITTED AS AN INPATIENT FOR MEDICAL TREATMENT. REVIEWED THE PROGRAMMING, AND THE RESERVOIR WAS SHOWING THE SAME AMOUNT OF INSULIN AS SHOWN ON THE STATUS SCREEN. DURING THE CALL, IT WAS MENTIONED THAT THE CUSTOMER HAD STRESS. THE CALLER BELIEVES THAT THE BASAL RATE MAY NEED TO BE RE-EVALUATED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340966 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR