BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 6076272 · Received November 3, 2016

    Report

    Report Number
    2032227-2016-39617
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    October 12, 2016
    Report Date
    November 8, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A FAULTY FORCE SENSOR RESISTOR. THE PUMP PASSED THE IDLE CURRENT, RUN CURRENT, SELF TEST, OFF NO POWER, UNEXPECTED RESTART, BASIC OCCLUSION, DISPLACEMENT AND REWIND TESTS. UNABLE TO PERFORM THE OCCLUSION OR EXCESSIVE NO DELIVERY TESTS DUE TO THE PRIME ANOMALY. THE PUMP DOWNLOADED PROPERLY TO THE CARE LINK PRO SOFTWARE. THE PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW AND A CRACKED RESERVOIR TUBE LIP.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD A PRIME/FILL ANOMALY. THE CUSTOMER'S BLOOD GLUCOSE WAS 216 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT THE ISSUE WAS NOT RESOLVED AFTER TROUBLESHOOTING. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO REVERT TO BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729084 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR