BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4110782 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27940
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS PROGRAMMED WITH A TEST TRANSMITTER AND THE GLUCOSE SENSOR SIMULATOR AND COMMUNICATED PROPERLY. THE INSULIN PUMP DATA TRANSFERRED PROPERLY. NO UNEXPECTED SOFTWARE ERROR ALARMS. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW AND A SCRATCHED RESERVOIR TUBE 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP WAS UNABLE TO UPLOAD METER READINGS. DURING TROUBLESHOOTING, THE METER'S IDENTIFICATION WAS VERIFIED. CUSTOMER STATED THEY DID NOT RECALL ANY SIGNIFICANT EVENTS THAT LEAD TO THE ALARM OR IF THE DEVICE WAS EXPOSED TO MOISTURE. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT PROVIDED AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589596 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR