BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4233082 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48647
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD A LOW BLOOD GLUCOSE ALERT AND A LOW THRESHOLD SUSPEND ALERT. CUSTOMER HAD DIFFERENCES BETWEEN SENSOR GLUCOSE AND BLOOD GLUCOSE READINGS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS AROUND 149 MG/DL AND THE SENSOR GLUCOSE WAS AROUND 49 MG/DL. THERE WAS ABOUT A 100 POINTS DIFFERENCE. CUSTOMER STATED THAT IT USUALLY HAPPENS ON THE 5TH OR 6TH DAY OF WEARING HIS SENSOR. CUSTOMER WAS ADVISED TO CALIBRATE ONLY WHEN STABLE AND NO MORE THAN 3-4 TIMES PER DAY. CUSTOMER WAS ADVISED TO INSERT THE SENSOR IN THE AREA WHERE PRESSURE CANNOT BE APPLIED TO THE SENSOR. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715455 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR