BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4860725 · Received June 22, 2015

    Report

    Report Number
    3004209178-2015-67750
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RECEIVED WITH A CONSTANT MOTOR ERROR ALARM DURING THE REWIND DUE TO AN OUT OF PHASE MOTOR ENCODER SIGNAL. UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO THE CONSTANT MOTOR ERROR ALARM. THE PUMP WAS ALSO RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS AND MINOR SCRATCHES ON THE LCD WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE WAS GETTING A MOTOR ERROR ALARM ON THE INSULIN PUMP. CUSTOMER WAS GETTING A REGULAR BASAL DELIVERY WHEN THE ALARM OCCURRED. CUSTOMER'S BLOOD GLUCOSE WAS 247 MG/DL. CUSTOMER WAS ASSISTED WITH CLEARING THE ALARM. CUSTOMER USES THE SENSOR FEATURE ON THE PUMP. IT WAS EXPLAINED THAT A FALSE MOTOR ERROR MAY BE CAUSED BY VIEWING THE SENSOR GLUCOSE GRAPH WHILE THE PUMP IS DELIVERING A BOLUS. CUSTOMER WAS ADVISED THAT THEY CAN REDUCE THE LIKELIHOOD OF THESE OCCURRENCES BY ALLOWING THE BOLUS DELIVERY TO COMPLETE BEFORE ACCESSING THE SENSOR GLUCOSE GRAPH. CUSTOMER STATED THAT THEY ARE UNABLE TO COMPLETE THE REWIND SEQUENCE. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ALSO ADVISED TO REVERT TO A BACK-UP PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403960 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR