BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4200480 · Received September 17, 2014

    Report

    Report Number
    2032227-2014-23874
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 2, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    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. 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

    CUSTOMER REPORTED HER INSULIN PUMP HAD A FALSE THRESHOLD SUSPEND. CUSTOMER'S SENSOR READING WAS 50 MG/DL, BUT HER BLOOD GLUCOSE WAS 101 MG/DL. CUSTOMER WAS EDUCATED ON THE DIFFERENCES BETWEEN SENSOR GLUCOSE READINGS AND BLOOD GLUCOSE LEVELS. SHE WAS TOLD TO MONITOR THE ISSUE AND CALL BACK IF NEEDED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575455 530G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR