BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4240505 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49722
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 TEST TRANSMITTER AND GLUCOSE SENSOR SIMULATOR COMMUNICATED PROPERLY WITH THE INSULIN PUMP AND NO UNEXPECTED LOST SENSOR ALARM WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, A CRACKED CASE AT A DISPLAY WINDOW CORNER, MINOR SCRATCHES ON THE DISPLAY WINDOW AND A SCRATCHED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP DISPLAYED AN INCORRECT SENSOR AGE. THE BLOOD GLUCOSE READING WAS 147 MG/DL. THE CUSTOMER STATED THAT HE HAD BEEN OFF THE INSULIN PUMP THERAPY FOR ABOUT A MONTH, BUT WHEN HE LOOKED AT THE SENSOR AGE, IT SHOWED 48 DAYS AND 16 HOURS. HE NOTED THAT THERE WAS A SENSOR END ALERT ON THE HISTORY ABOUT A MONTH AND A HALF PRIOR TO THE CALL. HE WAS UNABLE TO TROUBLESHOOT AT THE TIME OF CALL. ADVISED DISCONTINUATION AND REPLACEMENT OF THE INSULIN PUMP DUE TO THE SENSOR STATUS BEING INCORRECT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724121 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR