BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4203378 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-43579
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 27, 2014
    Report Date
    September 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED LOW SUSPEND. CUSTOMER STATED THERE WAS AN ISSUE WITH THE SENSORS, HE STATED HE GOT THRESHOLD SUSPEND ALARM. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 138 MG/DL. CUSTOMER STATED THAT SENSOR GLUCOSE READING WAS 64 MG/DL. AND SUSPEND THRESHOLD LIMIT WAS 65 MG/DL. EXPLAINED TO CUSTOMER THE DIFFERENCES OF SENSOR GLUCOSE AND BLOOD GLUCOSE READING. THE BLOOD GLUCOSE ADJUSTED DURING THE TROUBLESHOOTING TO 112 MG/DL. CUSTOMER WAS LAYING DOWN AND ADVISED THE CUSTOMER PRESSURE ON SITE CAN BE A FACTOR THAT READING MAYBE LOW BUT THE ACTUAL WAS NOT. ADVISED THE CUSTOMER IF ALERT COMES BACK TO CLEAR AND RESTART HIS BASAL ON THE INSULIN PUMP. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683262 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR