BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4200422 · Received September 17, 2014

    Report

    Report Number
    2032227-2014-23868
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED HIS INSULIN PUMP IS ALARMING NO DELIVERY. HE JUST SPOKE WITH SOMEONE FROM HELP LINE AND HIS DEVICE WAS WORKING FINE, SO CUSTOMER RECONNECTED TO THE DEVICE. THE DEVICE ALARMED NO DELIVERY AGAIN. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE ALARM WAS CLEARED WITH THE ESC AND ACT BUTTON. THE CONNECTION WAS VERIFIED. INSULIN EXITED THE TUBING WHEN CUSTOMER MANUALLY PUSHED IT WITH A PLUNGER. CUSTOMER REINSERTED THE RESERVOIR AND RAN A MANUAL PRIME AND THE DEVICE DID NOT ALARM NO DELIVERY. CUSTOMER WAS ADVISED THE DEVICE IS WORKING AS DESIGNED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575453 530G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR