BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4141707 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33279
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A MOTOR ERROR ALARM ON THE INSULIN PUMP. CUSTOMER WAS CONTACTED AND INFORMED THAT THE PUMP THAT HE RECEIVED IS NOT A REFURBISHED PUMP, BUT A NEW PUMP. CUSTOMER STATED THAT HE WOULD LIKE TO GET A REPLACEMENT SENSOR SINCE HE HAD TO TAKE THE SENSOR OUT WHEN HE HAD A MOTOR ERROR. CUSTOMER STATED THAT IN THE LAST 15 YEARS, HE HAS NEVER HAD TO BE OFF THE PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 169 MG/DL AT THE TIME OF THE CALL. CUSTOMER STATED THAT HE DOES NOT NEED TO TROUBLESHOOT FOR THE BLOOD GLUCOSE SINCE HE IS WORKING ON THE BASAL RATES WITH HIS HEALTH CARE PROFESSIONAL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621230 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR