BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4792021 · Received May 22, 2015

    Report

    Report Number
    3004209178-2015-58802
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    April 29, 2015
    Report Date
    May 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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

    CUSTOMER CALLED TO REPORT THAT THEY ARE EXPERIENCING LOW BLOOD GLUCOSE LEVELS. CUSTOMER STATED THE PARAMEDICS TREATED HER WITH A GLUCAGON SHOT BUT SHE WAS NOT ADMITTED TO THE HOSPITAL. CUSTOMER'S BLOOD GLUCOSE READING WAS 23 MG/DL. CUSTOMER STATED THAT HER MENSTRUAL PERIOD MAY HAVE LED TO LOW BLOOD GLUCOSE LEVELS. OFFERED TO TROUBLESHOOT FOR LOW BLOOD GLUCOSE LEVELS BUT CUSTOMER DECLINED SINCE SHE DOES NOT BELIEVE IT WAS PUMP RELATED. PRODUCT IS NOT BEING RETURNED OR REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333846 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR