BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE MMT-7008A

    MDR report key: 4060649 · Received September 4, 2014

    Report

    Report Number
    2032227-2014-14405
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: RELIABILITY ANALYSIS: INSPECTED 1 OPENED/USED ENLITE SENSOR AND PERFORMED BICARBONATE BUFFER TEST PER (B)(4). SENSOR FAILED PER SPECIFICATION DUE TO HIGH READINGS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ISSUES WITH SENSOR GLUCOSE VERSES BLOOD GLUCOSE DIFFERENCES. CUSTOMER'S BLOOD GLUCOSE READING WAS 171 MG/DL. TROUBLESHOOTING WAS DONE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541345 SENSOR ENLITE MMT-7008A OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR