BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4142061 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33344
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    August 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT

    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 BY THE CUSTOMER THAT THEIR INSULIN PUMP ALARMED MOTOR ERROR AND NO DELIVERY. DURING TROUBLESHOOTING, CUSTOMER STATED THAT THEY DO USE THE SENSOR FEATURE AND WAS ABLE TO REWIND THE INSULIN PUMP. CUSTOMER STATED THEY DID NOT RECALL ANY SIGNIFICANT EVENTS THAT LED TO THE ALARM OR IF THE DEVICE WAS EXPOSED TO MOISTURE. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 93 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621480 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR