BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4492451 · Received February 6, 2015

    Report

    Report Number
    3004209178-2015-92436
    Event Type
    Injury
    Date Received
    February 6, 2015
    Date of Event
    January 19, 2015
    Report Date
    February 5, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. SEE MANUFACTURE REPORT NUMBER 2032227-2015-05189.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HE WAS AT THE HOSPITAL FOR FOLLOW UP WORK. CUSTOMER REPORTED THE ADVERSE EVENT OCCURRED ON (B)(6) 2015. BLOOD GLUCOSE WAS 467 MG/DL, TREATED WITH MANUAL INJECTION. CUSTOMER STATED NO SIGNIFICANT EVEN THAT MAY HAVE LEAD TO THE EMERGENCY ROOM VISIT. CUSTOMER WAS NOT HOSPITALIZED WAS RELEASED FROM THE EMERGENCY ROOM. CUSTOMER STATED THE CANNULA WAS NOT BET. SITE WAS NOT SORE OR IRRITATED. INSULIN WAS NOT EXPIRED. CUSTOMER WAS ADVISED TO DO A COMPLETE SET. CUSTOMER DECLINED TROUBLESHOOTING AS HE WAS DRIVING. CUSTOMER HAD TO LOW BLOOD GLUCOSE EVENTS (B)(6) 2015 AND (B)(6) 2015, 27 MG/DL AND 31 MG/DL. CUSTOMER WAS NOT ADMITTED SPOUSE ADMINISTERED GLUCAGON SHOTS. CUSTOMER WAS NOT IN A CAR ACCIDENT. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86883 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization