BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4822325 · Received June 5, 2015

    Report

    Report Number
    3004209178-2015-63049
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    May 15, 2015
    Report Date
    May 18, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. THE PUMP WAS RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATION. NO OFF NO POWER ANOMALIES WERE NOTED. NO ALARMS WERE NOTED. THE PUMP HAD MINOR SCRATCHES ON THE LCD WINDOW.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMMUNICATION ERROR AND OFF NO POWER. THE CUSTOMER WAS UNABLE TO TROUBLESHOOT BECAUSE THE INSULIN PUMP KEPT RESTARTING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 220 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE 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
    365625 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR