BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4061945 · Received September 4, 2014

    Report

    Report Number
    2032227-2014-16821
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP FAILED DISPLACEMENT TEST FOLLOWED BY A MOTOR ERROR ALARM DURING REWIND DUE TO MOTOR ENCODER BEING OUT OF PHASE. UNABLE TO PERFORM FUNCTIONAL TEST OR DELIVERY VOLUME ACCURACY TEST DUE TO MOTOR ENCODER BEING OUT OF PHASE. THE DEVICE WAS RECEIVED WITH CRACKED CASE ON DISPLAY WINDOW CORNERS, SCRATCHED LCD WINDOW, AND CRACKED RESERVOIR TUBE LIP. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. NO UNEXPECTED FAILED BATTERY TEST ALARM WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HAVING DIFFICULTIES WITH THE FAILED BATTERY TEST ALARMS. THE CUSTOMER STATED THAT THEY WERE ADVISED TO REPLACE THE BATTERY, BUT THAT DID NOT WORK. THE CUSTOMER HAD REPORTED THE ISSUE IN JUNE. THE INSULIN PUMP WAS NOT DELIVERING ANY INSULIN BECAUSE THEY COULD NOT PASS THE FAILED BATTERY TEST. THE CUSTOMER'S BLOOD GLUCOSE WENT VERY LOW AND THEY WENT TO THE HOSPITAL. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE HOSPITALIZATION WAS 17 MG/DL. THE CUSTOMER WAS TREATED AND RELEASED OVERNIGHT. THE CUSTOMER'S RECENT BLOOD GLUCOSE WAS 213 MG/DL. THE CUSTOMER DISCONTINUED THE USE OF THE INSULIN PUMP SINCE THE HOSPITALIZATION AND THEY WERE REQUESTING A REPLACEMENT INSULIN PUMP WITHOUT GOING THROUGH ANY TROUBLESHOOTING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540617 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization