BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3945420 · Received July 21, 2014

    Report

    Report Number
    3004209178-2014-87816
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD INACCURATE FLUCTUATION IN ITS BLOOD GLUCOSE READINGS AND THE CUSTOMER EXPERIENCE A LOW BLOOD GLUCOSE EPISODE. THE BLOOD GLUCOSE READING WAS 28 MG/DL. THE CUSTOMER STATED THAT THE RANGE IS REALLY TOO LARGE OF A DIFFERENCE SOMETIMES AND THAT SHE RECEIVED A LOW BLOOD GLUCOSE ALERT. SHE TREATED WITH JUICE. THE CUSTOMER WAS AWARE OF ADVISEMENT NOT TO TREAT WITH SENSOR GLUCOSE READINGS. SHE ALSO STATED THAT ALMOST A MONTH PRIOR, SHE HAD ANOTHER OCCASION WHEN DID NOT FEEL WELL, WAS VERY WEAK AND TREATED WITH JUICE. SHE REPORTED THAT THE BLOOD GLUCOSE WAS LOW DUE TO A MISCALCULATION RELATED TO THE PAST BLOOD GLUCOSE READING; SHE DID NOT RECHECK THE BLOOD GLUCOSE AT THE TIME OF THE BOLUS. CUSTOMER IS PRONE TO RAPID DROPS IN BLOOD GLUCOSE. SHE DECLINED TROUBLESHOOTING FOR LOW BLOOD GLUCOSE. THE INSULIN PUMP ALSO HAD A SCRATCH ON THE DISPLAY, BUT THE CUSTOMER CONFIRMED THAT SHE IS ABLE TO SEE THE SCREEN. ADVISED SENSOR PROTOCOL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425566 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR