BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 6103921 · Received November 15, 2016

    Report

    Report Number
    2032227-2016-42388
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    November 10, 2016
    Report Date
    November 28, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED STUCK IN THE MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY AND E70 ALARM WAS CONFIRMED IN HISTORY FILE. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED; THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING. NO A35 ALARM. THE INSULIN PUMP PASSED DISPLACEMENT TEST, BASIC OCCLUSION TEST, PRIME TEST, OPERATING CURRENTS, SELF-TEST AND OFF NO POWER. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW AND CRACKED CASE AT THE DISPLAY WINDOW CORNER.

    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL TO HAVE RECEIVED A MOTION SENSOR TEST FAILURE ALARM, MOTOR ERROR ALARM AND A CUSTOMER REPORTED VIA PHONE CALL TO HAVE RECEIVED A MOTION SENSOR TEST FAILURE ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 180 MG/DL. AFTER TROUBLESHOOTING, CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755613 530G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR