BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 6079794 · Received November 4, 2016

    Report

    Report Number
    2032227-2016-39995
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    October 28, 2016
    Report Date
    November 16, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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. 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).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH CURRENTS IN SPECIFICATION. THE INSULIN PUMP PASSED SELF-TEST AND UNEXPECTED RESTART ERROR ALARM TEST. NO UNEXPECTED RESTART ALARM NOTED. THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE KEYPAD TRACE. THE INSULIN PUMP HAD MINOR SCRATCHES LCD WINDOW, CRACKED CASE NEAR DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP AND CRACKED LCD WINDOW. THE INSULIN PUMP PASSED REWIND TEST, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. THE NUMBERS DOES NOT RAMP UP ON ITS OWN OR SCROLL BAR MOVING WITH NO INPUT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED UNEXPECTED RESTART ALARM AND THEY WERE UNABLE TO CLEAR THE ALARM WITH ACT AND ESC BUTTON. THE CUSTOMER ALSO REPORTED THAT THE BOLUS AMOUNT KEPT SCROLLING ON THE SCREEN. THE CUSTOMER'S BLOOD GLUCOSE WAS 130 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731247 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR