BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4153442 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-35155
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    August 31, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION, PRIME, AND DISPLACEMENT TESTS. HOWEVER THE INSULIN PUMP WAS RECEIVED WITH STUCK WITH MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND IT PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING TESTING. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE LCD WINDOW, CRACKED CASE NEAR DISPLAY WINDOW CORNERS, AND 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A MOTOR ERROR ALARM ON THE INSULIN PUMP, HE REWOUND THE PUMP, IT SHUT OFF, AND THE SETTINGS WERE ERASED. THE MOTOR ERROR OCCURRED DURING BASAL DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE WAS AROUND 200 MG/DL. DURING TROUBLESHOOTING, THE CUSTOMER STATED THE INSULIN PUMP WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD. THE CUSTOMER USES THE SENSOR FEATURE ON THE INSULIN PUMP. HE WAS ADVISED THAT A FALSE MOTOR ERROR ALARM COULD BE CAUSED BY VIEWING THE SENSOR GLUCOSE GRAPH WHILE THE INSULIN PUMP DELIVERS A BOLUS. THE CUSTOMER STATED HE WAS ABLE TO REWIND THE INSULIN PUMP AND WAS ADVISED TO DISCONTINUE USE AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630879 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR