BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4515578 · Received February 13, 2015

    Report

    Report Number
    3004209178-2015-93970
    Event Type
    Injury
    Date Received
    February 13, 2015
    Date of Event
    February 3, 2015
    Report Date
    February 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. REFER TO MANUFACTURE REPORT 203227-2015-06429.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE LEVELS AND THAT THE SENSOR GLUCOSE READINGS WERE INACCURATE. THE BLOOD GLUCOSE READING WAS 37 MG/DL, COMPARED WITH THE SENSOR GLUCOSE READING OF 273 MG/DL. THE CUSTOMER REPORTED THAT THE SENSOR AND BLOOD GLUCOSE READINGS WERE HAD DIFFERENCES OF 100 TO 200 UNITS. SHE STATED THAT THE SENSOR WOULD INDICATE THAT SHE HAD HIGH BLOOD GLUCOSE WHEN SHE WAS LOW, AND VICE VERSA. SHE ADVISED THAT THE BLOOD GLUCOSE READING REPORTED WAS A NORMAL RANGE FOR HER. SHE DECLINED TROUBLESHOOTING FOR THE MATTER AND WAS ADVISED TO MONITOR THE DEVICE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110060 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR