BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR

    MDR report key: 4252122 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-53113
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS: INSPECTED 1 OPENED/USED SENSOR AND PERFORMED BBS SOLUTION TEST AND SENSOR FAILED PER SPEC NO ISIG READING DETECTED DUE TO FOUND SENSOR DAMAGE. ALSO FOUND CANNULA BENT UNABLE TO CONFIRM CUSTOMER RECEIVED SENSOR IN SAID CONDITION DUE TO CUSTOMER RETURNED OPENED/USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER'S TRANSMITTER DOES NOT BLINK WHEN ATTACHED TO THE SENSOR. THE CUSTOMER'S BLOOD GLUCOSE WAS 50 MG/DL. THE CUSTOMER ALSO STATED THEY HAD TREATED FOR THEIR BLOOD GLUCOSE. IT WAS ALSO FOUND THE CUSTOMER RECEIVED A LOST SENSOR ALARM. CUSTOMER DECLINED TO TROUBLESHOOT FOR THEIR INSULIN PUMP. CUSTOMER ALSO STATED THEIR SENSOR WAS SLIGHTLY BENT WHEN THEY HAD REMOVED IT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737725 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C A234

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR