BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4090412 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23106
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED INACCURATE SENSOR READINGS THAT CAUSED HER INSULIN PUMP TO GO INTO A FALSE THRESHOLD SUSPEND MODE. CUSTOMER'S BLOOD GLUCOSE WAS 326 MG/DL, BUT HER SENSOR READING WAS 211 MG/DL. WHEN CHECKING THE HISTORY, CUSTOMER STATED SHE HAS HAD THRESHOLD SUSPENDS AND HER SENSORS ARE RARELY ACCURATE. IN TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE, NO ANOMALIES WITH THE INSULIN PUMP WERE FOUND. CUSTOMER WAS ADVISED TO MONITOR THE ISSUE AND CALL BACK IF NEEDED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568588 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR