BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3813001 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-84626
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 25, 2014
    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.

    Description of Event or Problem · 1

    THE CUSTOMER POSTED THAT HE WAS NOT FELLING LOW, BUT THE SENSOR WAS READING 52MG/DL, AND WHEN HE CHECKED IT WAS 129MG/DL, THEN IT DROPPED TO 68MG/DL IN TEN MINUTES. CONTACTED THE CUSTOMER REGARDING POST, AND SHE STATED THAT THE SENSOR STILL WAS WORKING FINE AND HAD STILL ON. TROUBLESHOOTING WAS DECLINED AS CUSTOMER WAS TOLD TO CALL BACK WHEN SHE HAS ANY ISSUES AND THE SENSOR WOULD BE REPLACED AS NEEDED. THE CALLER MENTIONED HAVING ISSUES WITH THE RESERVOIRS, AND HE COULD NOT GET THE PLUNGER TO PUSH INSULIN OUT. THE CALLER STATED BEING HOSPITALIZED DUE TO NONE DIABETES RELATED ISSUES AND NOTHING HAS TO DO WITH THE INSULIN PUMP; HE HAD A CATARACTS SURGERY. THE CALLER HAD HIGH BLOOD GLUCOSE WHILE STAYING IN THE HOSPITAL. NO FURTHER INFORMATION AS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290380 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization