BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4123113 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29464
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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

    IT IS REPORTED THAT A CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE OF 26 MG/DL. THE CUSTOMER WAS TREATED FOR THE LOW BLOOD GLUCOSE WITH A GLUCOSE TABLET. THE CUSTOMER WAS INFORMED THAT THERE COULD BE MANY REASONS FOR LOW BLOOD GLUCOSE. THE CUSTOMER WAS HOSPITALIZED WHERE LATER SHE WAS ASSISTED WITH TROUBLE SHOOTING ON HER INSULIN PUMP. THE CUSTOMER SEEMED TO HAVE RECEIVED A LOST SENSOR ALERT. THE CUSTOMER'S INSULIN PUMP WORKS AS DESIGNED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600756 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR