BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4203827 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-43730
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 27, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED/USED ENLITE SENSOR WAS INSPECTED AND TESTED AND IT PASSED PER SPECIFICATIONS WITH ACCURATE READINGS. THE CANNULA WAS FOUND BENT ON THE SENSOR, UNABLE TO CONFIRM IF THE CUSTOMER RECEIVED THE SENSOR IN SAID CONDITIONS AS DEVICE WAS RETURNED OPENED/USED.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY WOKE UP IN THE MORNING FEELING WEAK AND WOBBLY, HOWEVER, DID NOT RECEIVE AN ALARM FROM THE INSULIN PUMP STATING THAT THEY WERE HAVING LOW BLOOD GLUCOSE READINGS. CUSTOMER STATED THAT SHE CHECKED HER BLOOD GLUCOSE READINGS AND THEY WERE 47 MG/DL AND THE SENSOR WAS READING 147 MG/DL. CUSTOMER ALSO MENTIONED RECEIVING A FALSE LOW ALERTS. CUSTOMER DECLINED TROUBLESHOOTING AND STATED THAT THE REASON FOR THE DIFFERENCE WAS THAT THE SENSOR WAS KINKED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684847 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR