BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR

    MDR report key: 4223028 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-46835
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS INSPECTED 1 OPENED OR USED SENSOR AND PERFORMED BICARBONATE BUFFER TEST. SENSOR PASSED PER SPECIFICATION WITH ACCURATE READINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE OF 44 MG/DL; TREATED WITH FOOD. IT WAS STATED THAT THE CUSTOMER RECEIVED A LOST SENSOR ALERT. THE INSULIN PUMP IS NOT COMMUNICATING WITH THE TRANSMITTER. CUSTOMER REMOVED THE SENSOR AND IT WAS NOT BENT OR DAMAGED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707947 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C L143

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR