BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4103810 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26560
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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. 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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE, PER VARIANCE 5.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE DISCREPANCIES BETWEEN THE SENSOR GLUCOSE VALUES AND THE BLOOD GLUCOSE VALUES. THE SENSOR GLUCOSE WAS 40 MG/DL BUT THE BLOOD GLUCOSE WAS 193 MG/DL. THEN, THE INSULIN PUMP ALARMED CALIBRATION ERROR. THE CUSTOMER STATED THAT THEY WERE EXPERIENCING SLEEP DEPRIVATION. THEY CALIBRATE THE DEVICE 6-10 TIMES A DAY. THE INSULIN PUMP HAD GONE INTO AN INAPPROPRIATE THRESHOLD SUSPEND MODE DUE TO THE LOW SENSOR GLUCOSE VALUE. THERE WERE 2 CALIBRATION ERRORS FOLLOWED BY A CHANGE SENSOR ALARM, SO THE CUSTOMER COULD NOT CONTINUE SENSING. THE CUSTOMER DECLINED TROUBLESHOOTING THE CHANGE SENSOR AND LOST SENSOR ALARMS. THEY WILL RETURN THE SENSOR FOR ANALYSIS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583874 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR