BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4813462 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-61749
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 13, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT RECEIVED WITH CRACKED AND BLEEDING LCD GLASS, BROKEN OFF END CAP, AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT DAMAGE TO THE INSULIN PUMP. CUSTOMER ALSO REPORTED A BLANK DISPLAY SCREEN. CUSTOMER'S BLOOD GLUCOSE READING WAS 110 TO 120 MG/DL. TROUBLESHOOTING WAS DONE. ADVISED DISCONTINUATION OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN PER HEALTH CARE PROFESSIONAL. PRODUCT IS BEING RETURNED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356788 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR