BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 6199217 · Received December 22, 2016

    Report

    Report Number
    2032227-2016-52045
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    December 15, 2016
    Report Date
    January 12, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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 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).

    Additional Manufacturer Narrative · 1

    THE PUMP ALARMED MOTOR ERROR DURING THE REWIND DUE TO AN OUT OF PHASE MOTOR ENCODER SIGNAL. UNABLE TO VERIFY THE MOTOR POSITION ENCODER ERROR ALARM AND WAS UNABLE TO PERFORM THE BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY, DISPLACEMENT, SELF TEST, UNEXPECTED RESTART AND ALL OPERATING CURRENT MEASUREMENTS DUE TO THE CONSTANT MOTOR ERROR ALARM. THE PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED IN TO REPORT A MOTOR POSITION ENCODER ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED, AND WAS INFORMED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849364 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR