BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4110556 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27395
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 15, 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
    AL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP KEPT ALARMING MOTOR ERROR FOR TWO WEEKS. CUSTOMER STATED HE DOES USE THE SENSOR AND HIS BLOOD GLUCOSE LEVELS HAVE BEEN HIGH. CUSTOMER'S CURRENT BLOOD GLUCOSE WAS 121 MG/DL. CUSTOMER STATED THE MOTOR ERROR OCCURRED WHILE CUSTOMER WAS ASLEEP. CUSTOMER STATED, THE DEVICE WAS NOT DROPPED OR WET, WHEN ASKED IF CUSTOMER RECALLED ANY SIGNIFICANT EVENTS THAT MAY HAVE CAUSED THE DEVICE TO ALARM. THE DEVICE WAS NOT EXPOSED TO AN MRI. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE DEVICE. CUSTOMER DOES USE THE SENSOR FEATURE. CUSTOMER WAS ADVISED ABOUT FALSE MOTOR ERROR ALARMS OCCURRING, IF CUSTOMER TRIED TO SEE THE SENSOR GLUCOSE GRAPH WHILE BOLUSING. CUSTOMER WAS ABLE TO REWIND THE DEVICE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591391 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR