BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4862663 · Received June 23, 2015

    Report

    Report Number
    3004209178-2015-67817
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    May 6, 2015
    Report Date
    June 4, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A CRACKED AND BLEEDING LCD GLASS. THEY WERE UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO THE LCD DAMAGE. THE INSULIN PUMP HAD A CRACKED BELT CLIP SLOT, A CRACKED RESERVOIR TUBE LIP, A SCRATCHED RESERVOIR TUBE WINDOW, AND A MINOR SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A CRACK. CUSTOMER STATED THAT THE PUMP WAS RESET AND EVERYTHING WAS FINE UNTIL THE NEW BATTERY. CUSTOMER STATED THAT THE SETTINGS WERE CLEARED. CUSTOMER HAD A PROBLEM THAT OCCURRED AFTER THE PUMP SHUT OFF AND A NEW BATTERY WAS INSERTED. CUSTOMER CAN'T SEE THE SCREEN TO CORRECT THE BASAL. CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ALSO ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407147 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR