BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4812950 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-61669
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 9, 2015
    Report Date
    May 12, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH BLANK DISPLAY DUE TO THE INTERFACE BOARD HAS A BROKEN SOLDER JOINT. UNABLE TO VERIFY A21 ALARM DUE TO BLANK DISPLAY. THE INSULIN PUMP HAS SEVERELY SCRATCHED DISPLAY WINDOW 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED UNEXPECTED RESTART AND HAD A BLANK DISPLAY. THE CUSTOMER'S BLOOD GLUCOSE WAS 147 MG/DL AT THE TIME OF THE BLANK DISPLAY, AND HER MOST RECENT BLOOD GLUCOSE WAS 60 MG/DL. THE CUSTOMER OBSERVED A LITTLE CORROSION ON THE SIDE OF THE BATTERY COMPARTMENT. SHE WAS UNABLE TO TROUBLESHOOT FOR THE UNEXPECTED RESTART DUE TO THE BLANK DISPLAY. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED TO REPLACE THE INSULIN PUMP AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354832 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR