BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 6194152 · Received December 21, 2016

    Report

    Report Number
    2032227-2016-52078
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    November 1, 2016
    Report Date
    December 1, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS REPORT PROVIDED IN THE INITIAL REPORT WAS INCORRECT. THE CORRECTED DATA WILL BE PROVIDED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    MOTOR ERROR ALARM DURING THE BASIC OCCLUSION TEST AND UNABLE TO PRIME DURING THE PRIME/COMPROMISED FORCE SENSOR SYSTEM TEST DUE TO FAULTY FORCE SENSOR RESISTOR. INSULIN PUMP PASSED THE OPERATING CURRENTS MEASUREMENT, SELF-TEST, UNEXPECTED RESTART ERROR TEST, REWIND, BASIC OCCLUSION TEST, AND DISPLACEMENT TEST. UNABLE TO PERFORM THE OCCLUSION TEST AND NO DELIVERY TEST DUE TO MOTOR ERROR ALARM. MOTOR PASSED MOTOR TEST. INSULIN PUMP MONITORED FOR SEVERAL DAYS AND NO BLANK DISPLAY ANOMALY NOTED. NO DAMAGE FOUND ON CONNECTOR/LCD ISOLATION TAPE NOTED. NO DAMAGE OR CORROSION FOUND ON BATTERY CAP NOTED. INSULIN PUMP HAD CRACKED BATTERY TUBE THREADS, RESERVOIR TUBE, RESERVOIR TUBE LIP, AND MINOR SCRATCHED DISPLAY WINDOW. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 103 MG/DL. THERE WAS AN EXTRA RING IN THE CAP. THE DISPLAY DID NOT RETURN AFTER TROUBLESHOOTING. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847401 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR