BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3854456 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-85285
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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

    CUSTOMER RECEIVED A CALL FROM OUR OUTREACH PROGRAM, ASKING ABOUT CUSTOMER'S HOSPITALIZATION. CUSTOMER STATED THAT SHE DID NOT THINK HER HOSPITALIZATION WAS DUE TO HER BLOOD GLUCOSE METER OR SENSOR. SHE SAID THAT SHE WAS IN AN ACCIDENT ON (B)(6) 2013 THAT REQUIRED NECK AND SPINAL SURGERY. MOST RECENTLY, IN MARCH, CUSTOMER HAD ANOTHER NECK SURGERY AND HAS BEEN ON MEDICATIONS THAT AFFECT HER BLOOD LEVELS. SHE SAYS THAT AFTER TAKING THE MEDICATION, SHE FEELS HER BLOOD GLUCOSE LEVEL GO LOW. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332607 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization