BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4156357 · Received October 9, 2014

    Report

    Report Number
    2032227-2014-35711
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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 WAS ENTERING CARBS AND THE PUMP DOES NOT CONSISTENTLY DO WHAT IT IS SUPPOSED TO DO. HEALTH CARE PROFESSIONAL (ENDOCRINOLOGIST) STATED IT APPEARED CUSTOMER ONLY ATE 12 TIMES IN THE LAST TWO WEEKS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 239 MG/DL. BOLUS WIZARD SETTINGS AND BOLUS HISTORY WERE ALSO REVIEWED, AND THERE ARE SOME BOLUSES THAT SHOW 0 CH. CUSTOMER STATED THAT SHE ENTERING CH BUT IT IS NOT SHOWING IT. A TEST BOLUS OF 1 CH WAS RAN WITH A BLOOD GLUCOSE LEVEL AND CUSTOMER STATED THAT IT IS SHOWING ACCURATELY IN THE HISTORY. CUSTOMER WAS ADVISED TO MONITOR EACH BOLUS THAT SHE DOES AND TO IMMEDIATELY CHECK THE BOLUS HISTORY TO ENSURE IT IS ACCURATE. CUSTOMER WAS TOLD TO CALL BACK AND REPORT ANY DISCREPANCIES IMMEDIATELY. CUSTOMER ALSO MENTIONED HAVING HIGH BLOOD GLUCOSE LEVELS BUT CUSTOMER DECLINED TO TROUBLESHOOT. CUSTOMER STATED THAT SHE WILL CALL BACK IF SHE HAS HIGH BLOOD GLUCOSE LEVELS AGAIN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634426 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR