BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4871506 · Received June 26, 2015

    Report

    Report Number
    3004209178-2015-68967
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 8, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    THE PUMP PASSED THE DISPLACEMENT, REWIND AND BASIC OCCLUSION TESTS. NO MOTOR ERROR ALARMS WERE NOTED. THE PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A FAULTY FORCE SENSOR. UNABLE TO PERFORM THE OCCLUSION OR EXCESSIVE NO DELIVERY TESTS DUE TO THE PRIME/FILL ANOMALY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND IT PASSED. THE PUMP ALSO HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A SCRATCHED CASE, CRACKED BATTERY TUBE THREADS, AND A CRACKED RESERVOIR TUBE.

    Description of Event or Problem · 1

    THE CUSTOMER'S FATHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR WHILE PRIMING. THE INSULIN PUMP ALARMED NO DELIVERY THREE TO FOUR TIMED WHILE MANUALLY PRIMING THE INSULIN PUMP. HE MAY HAVE WORN THE INSULIN PUMP DURING A X-RAY WHILE IN THE HOSPITAL. HE WAS UNABLE TO COMPLETE THE REWIND SEQUENCE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 112 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414427 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR