BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 6186852 · Received December 19, 2016

    Report

    Report Number
    2032227-2016-50679
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    September 5, 2016
    Report Date
    January 19, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP PASSED ALL FUNCTIONAL TESTING, INCLUDING THE IDLE CURRENT, RUN CURRENT, SELF TEST, OFF NO POWER, UNEXPECTED RESTART, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY, DISPLACEMENT AND REWIND TESTS. THE PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP AND A CRACKED RESERVOIR TUBE. THE DRIVE SUPPORT WAS INSPECTED AND NO ANOMALY WAS NOTED.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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

    CUSTOMER REPORTED VIA PHONE CALL THAT THE DRIVE SUPPORT CAP WAS DAMAGED. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONALS' INSTRUCTIONS. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. CUSTOMER AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836213 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR