BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4823753 · Received June 8, 2015

    Report

    Report Number
    3004209178-2015-63416
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Date of Event
    May 16, 2015
    Report Date
    May 19, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    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 INSULIN PUMP ALARMED DURING PRIME TEST DUE TO FAULTY FORCE SENSOR. NO UNEXPECTED MOTOR NOISE OR ABNORMAL SOUND HEARD DURING TESTING. THE INSULIN PUMP WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON LCD WINDOW AND SCRATCHED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA PHONE CALL, THAT THE CUSTOMER RECEIVED A COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME WAS UNKNOWN. TROUBLESHOOTING OCCURRED. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP, AND REVERT TO A BACK-UP 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
    368019 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR