BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4090378 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23077
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A MEDICAL INTERVENTION ON (B)(6) 2014 FOR LOW BLOOD GLUCOSE. THE CUSTOMER HAD A LOW BLOOD GLUCOSE AND HER COWORKERS CALLED THE PARAMEDICS. CUSTOMER HAD TREATED WITH FOOD. THE CUSTOMER STATED THE LOW BLOOD GLUCOSE WAS CAUSED BY STRESS. TROUBLESHOOTING WAS PERFORMED AND NO ANOMALIES WERE NOTED. CUSTOMER HAD SPOKEN TO HER HEALTH CARE PROFESSIONAL. ADVISED TO MONITOR THE INSULIN PUMP AND CALL BACK IF THE ISSUES PERSIST. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568249 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization