BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4760768 · Received May 8, 2015

    Report

    Report Number
    3004209178-2015-54472
    Event Type
    Injury
    Date Received
    May 8, 2015
    Date of Event
    March 17, 2015
    Report Date
    April 17, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    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

    THE CUSTOMER CALLED AND REPORTED THAT SHE HAD EXPERIENCED LOW BLOOD GLUCOSE 33 MG/DL AND BLOOD GLUCOSE WAS RUNNING LOW FOR A MONTH. AT THE TIME OF THE REPORT, CUSTOMER'S BLOOD GLUCOSE WAS 95 MG/DL, AND SHE HAD TREATED WITH GLUCOSE TABLETS. TROUBLESHOOTING WAS PERFORMED WITH THE INSULIN PUMP. THE DRIVE SUPPORT CAP APPEARED NORMAL. CUSTOMER BELIEVED BASAL SETTINGS WERE CORRECT. WHEN CUSTOMER CHECKED BLOOD GLUCOSE AGAIN, IT WAS 199 MG/DL, AND SHE TOOK INSULIN TO BRING THIS DOWN AGAIN. UPON CHECKING BOLUS HISTORY, IT WAS FOUND THE CUSTOMER'S LAST BOLUS DID NOT INCLUDE HER CARBOHYDRATES. CUSTOMER DID NOT SEE ANY BOLUSES WITH CARBOHYDRATES FOR APRIL 16 AND THOUGHT SHE MAY NOT HAVE BEEN ENTERING CARBOHYDRATES AND INSTEAD, JUST BOLUSING FOR CORRECTIONS WHEN HER BLOOD GLUCOSE RUNS HIGH, BRINGING HER BLOOD GLUCOSE LOW. UPON INSPECTION, THE RESERVOIR WAS SHOWING THE SAME AMOUNT OF INSULIN AS SHOWN ON THE STATUS SCREEN OF THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304388 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR