BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4455110 · Received January 27, 2015

    Report

    Report Number
    3004209178-2015-88002
    Event Type
    Malfunction
    Date Received
    January 27, 2015
    Date of Event
    January 9, 2014
    Report Date
    January 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: UNIT RECEIVED WITH CRACKED AND BLEEDING LCD GLASS. UNIT RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS. UNIT RECEIVED WITH MINOR SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A COSMETIC DAMAGE ON THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 93 MG/DL. THE CUSTOMER STATED THAT THE COSTOMETIC DAMAGE WAS NOG CAUSE BY A VEHICULAR ACCIDENT. THE CUSTOMER INSULIN PUMP HAD A CRACK ON THE PUMP SCREEN AND ON THE RESERVOIR COMPARTMENT. THE CUSTOMER'S WAS ADVISED THAT THE INSULIN PUMP NEED TO BE REPLACED. THE PATIENT WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN PER HEALTHCARE INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62134 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR