BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR

    MDR report key: 4233537 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48798
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS: INSPECTED 1 OPENED/USED SENSOR AND PERFORMED BICARBONATE BUFFER TEST DOP114-830. SENSOR PASSED WITH ACCURATE READINGS. ALSO FOUND CANULA BENT UNABLE TO CONFIRM CUSTOMER RECEIVED SENSOR IN SAID CONDITION DUE TO CUSTOMER RETURNED OPENED/USED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE WAS RECEIVING A GLUCOSE LEVEL READING OVER 500 MG/DL. CUSTOMER ALSO REPORTED RECEIVING A SENSOR ERROR. BLOOD GLUCOSE LEVEL WAS 142 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714657 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C D094

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR