BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 5753456 · Received June 27, 2016

    Report

    Report Number
    3004209178-2016-55823
    Event Type
    Injury
    Date Received
    June 27, 2016
    Date of Event
    May 31, 2016
    Report Date
    June 7, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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 REPORTED VIA PHONE CALL THAT SHE HAD THE INSULIN PUMP OFF FOR A WEEK AND DID NOT HAVE MONEY TO BUY A BATTERY. WHEN THE CUSTOMER PUT THE PUMP BACK ON, HER BLOOD GLUCOSE WAS 555 MG/DL. CUSTOMER'S CURRENT BLOOD GLUCOSE IS 202 MG/DL. CUSTOMER TREATED WITH THE PUMP. CUSTOMER PERFORMED THE HIGH PRESSURE TEST AND PASSED. CUSTOMER WAS ADVISED TO DO A COMPLETE SET CHANGE. CUSTOMER STATED THAT THE HIGH BLOOD GLUCOSE EVENT BEGAN ON (B)(6) 2016 OR AROUND 2 OR 3 WEEKS AGO. CUSTOMER WAS ADVISED TO MONITOR HER BLOOD GLUCOSE AND CONTACT HER HEALTH CARE PROFESSIONAL AS THE PUMP IS WORKING AS DESIGNED. IN A PREVIOUS CALL, CUSTOMER'S BLOOD GLUCOSE WAS 344 MG/DL AFTER TREATING WITH 14 UNITS OF INSULIN. CUSTOMER'S BLOOD GLUCOSE WAS 555 MG/DL AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406100 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other