BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4790830 · Received May 22, 2015

    Report

    Report Number
    3004209178-2015-58485
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 2, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INFORMATION WAS NOT INCLUDED WITH THE INITIAL REPORT. THE INFORMATION IS INCLUDED WITH THIS REPORT.

    Additional Manufacturer Narrative · 1

    NO BUTTON ERROR ALARMS WERE NOTED. HOWEVER, THE PUMP HAD AN UNRESPONSIVE ACT BUTTON DUE TO CORRODED KEYPAD TRACES. UNABLE TO PERFORM DISPLACEMENT TEST DUE TO THE UNRESPONSIVE BUTTON. THE PUMP ALSO HAD A CRACKED RESERVOIR TUBE LIP, A CRACKED LCD WINDOW AND A CRACKED CASE AT THE DISPLAY WINDOW CORNER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THE INSULIN PUMP ALARM BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE WAS 300 MG/DL. THE CUSTOMER STATED THAT THE ACT BUTTON ISN'T WORKING. CUSTOMER DOES NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ALARM. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334353 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR