BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4141694 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33421
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    August 22, 2014
    Report Date
    September 5, 2014
    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
    PATIENT

    Narratives

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. THIS MDR RELATED TO THE (B)(4)MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    THE CUSTOEMR REPORTED THAT THE INSULIN PUMP NEVER ALERTED HER TO HAVING AN EMPTY RESERVOIR. SHE STATED IT WOULD SHOW IF THERE WAS A LOW RESERVOIR, BUT NOT AN EMPTY RESERVOIR. THE CALLER WAS ADVISED THERE WAS ABOUT A 10 TO 11 UNIT DISCREPANCY IN WHAT THE STATUS SCREEN WAS SHOWING AND WHAT WAS REMAINING IN THE TUBING. THE CUSTOMER WAS INFORMED THAT THE EMPTY RESERVOIR NOTIFICATION WOULD ONLY OCCUR IF THE PISTON WERE TO BE FULLY EXTENDED. SHE WAS ADVISED THAT A DISPLACEMENT TEST COULD BE RUN TO CONFIRM THE INSULIN PUMP WAS WORKING. THE CUSTOMER'S BLOOD GLUCOSE WAS 120 MG/DL. THE CUSTOMER WAS NOT ABLE TO PERFORM TROUBLESHOOTING AT THE TIME. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621035 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR