BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 6135494 · Received November 30, 2016

    Report

    Report Number
    2032227-2016-46625
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    November 3, 2000
    Report Date
    December 6, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH WAS NOT INCLUDED WITH THE INITIAL MEDWATCH REPORT. THE ADDITIONAL INFORMATION HAS BEEN PROVIDED WITH THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL OF RECEIVING NO DELIVERY ALARMS DUE TO SITE AND SCAR TISSUE. CUSTOMER'S BLOOD GLUCOSE WAS 400 MG/DL, WHICH WAS TREATED WITH MANUAL INJECTION. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE DUE TO KNOWING THAT ISSUE WAS DUE TO SITE.

    Description of Event or Problem · 1

    THE RECORDING OF THE THIS CALL WAS REVIEWED FOR CLARIFICATION. DURING THE CALL, THE CUSTOMER STATED THAT SHE HAS BEEN HAVING ONGOING ISSUES WITH HER INFUSION SETS FOR THE PAST SEVEN YEARS. THE CUSTOMER HAS USED THREE DIFFERENT INFUSION SETS, BUT CONTINUES TO GET NO DELIVERY ALARMS DUE TO SCAR TISSUE AT THE INSERTION SITES. THE CUSTOMER USED HER ABDOMEN FOR MANY YEARS, AND CAN NO LONGER USE THAT AREA. THE CUSTOMER HAS RECENTLY STARTED USING HER BACK. THE CUSTOMER WANTED TO TRY THE NEWEST INFUSION SET AVAILABLE TO SEE IF THAT WOULD WORK BETTER FOR HER. THE CUSTOMER WAS GIVEN INFORMATION ON THE DIFFERENT NFUSION SETS, AND WAS ADVISED TO SPEAK TO HER DOCTOR ABOUT THE VARIOUS AREAS WHERE THE INFUSION SETS CAN BE INSERTED. THE CUSTOMER WAS ASKED TO BE TRANSFERRED SO THAT SHE CAN ORDER A SAMPLE OF THE NEWEST SETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785868 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other