BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4780657 · Received May 19, 2015

    Report

    Report Number
    3004209178-2015-57363
    Event Type
    Injury
    Date Received
    May 19, 2015
    Date of Event
    April 24, 2015
    Report Date
    April 28, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. PLEASE SEE MEDWATCH REPORT # 3004209178-2015-57362.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL BEING HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE CUSTOMER'S BLOOD GLUCOSE WAS OVER 1000 MG/DL, AND WITH SERUM THE BLOOD GLUCOSE WAS OVER 600 MG/DL. THE CUSTOMER STATED THAT WHEN SHE PRESSED THE SCROLL ON THE INSULIN PUMP DURING A LOW PREDICTION, THE BACKLIGHT DID NOT TURN ON. THE CUSTOMER STATED THAT SHE WAS TRYING TO GIVE HERSELF INSULIN, A SIGNAL FROM THE SENSOR WENT TO THE INSULIN PUMP, AND THE BACKLIGHT WENT OFF. SHE COMPLAINED OF NAUSEA. SHE HAD BEEN DIAGNOSED WITH PNEUMONIA A WEEK PRIOR TO THE HOSPITALIZATION. SHE WAS DISCONNECTED FROM THE DEVICE, TREATED WITH INTRAVENOUS DRIP UPON ADMISSION, AND WAS GIVEN THE INSULIN PUMP AFTER TREATMENT. SHE STATED THAT SHE WAS WEARING THE INSULIN PUMP AT THE TIME OF ADMISSION. SHE REPORTED THAT WHEN SHE HAD A LOW PREDICTION ALERT, SHE WAS UNABLE TO TURN THE BACKLIGHT ON. SHE STATED THAT SHE COULD NOT READ THE SCREEN AND ENDED UP IN THE HOSPITAL. SHE WAS TRANSFERRED TO A SENSOR TECHNICIAN FOR ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325156 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization