BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4200696 · Received September 17, 2014

    Report

    Report Number
    2032227-2014-23853
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE GLUCOSE MONITOR KEPT BEEPING AND WAS RUNNING HIGH AS 350MG/DL; THE CUSTOMER TREATED AND AT THE END OF CALL HER GLUCOSE LEVEL WAS 311 MG/DL. THE CUSTOMER WAS FRUSTRATED AND STATED THAT HIGH ALERTS IS OFF ON SENSORS, BUT THEY KEPT BEEPING. THE CALLER STATED THAT IN ONE OCCASION HER GLUCOSE WAS 33MG/DL, BUT SHE WAS UNABLE TO CONFIRM IF THE INSULIN PUMP ALARMED FOR HER LOW. THE CUSTOMER ALSO MENTIONED HAVING DISCREPANCIES WITH HER READINGS. SHE IS SENSITIVE TO INSULIN AND ALSO VERY ACTIVE AND SHE EXERCISES A LOT. ADVISED THE CALLER THAT SENSOR IS ALL ABOUT TIMING FOR CALIBRATION AND CHOOSE GOOD SITE FOR SENSOR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576089 530G INSULIN PUMP OZO MEDTRONIC PUERTO RICO OPERATIONS CO MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR