BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4891296 · Received July 6, 2015

    Report

    Report Number
    3004209178-2015-71175
    Event Type
    Injury
    Date Received
    July 6, 2015
    Date of Event
    June 14, 2015
    Report Date
    June 15, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH UNRESPONSIVE BUTTONS DUE TO CORRODED KEYPAD TRACES. THE UNIT WAS ALSO RECEIVED WITH A CRACKED CASE ON THE DISPLAY WINDOW CORNERS, CRACKED LIQUID CRYSTAL DISPLAY WINDOW, MINOR SCRATCHED LIQUID CRYSTAL DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP, AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD AN UNRESPONSIVE KEYPAD. SHE STATED THAT THE INSULIN PUMP HAD ALARMED LOW RESERVOIR AND THE CUSTOMER WAS CHANGING OUT THE INFUSION SET WHEN SHE OBSERVED THE ISSUE. THE CUSTOMER'S BLOOD GLUCOSE WAS 414 MG/DL. THE CUSTOMER STATED THAT SHE DID NOT FEEL WELL, ALTHOUGH SHE DID NOT SEEK MEDICAL ATTENTION AND TREATED WITH A BACK-UP PLAN. THE CUSTOMER DID NOT OBSERVE ANY SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUES. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CALLER 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
    435693 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other