BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE MMT-7008A

    MDR report key: 4060676 · Received September 4, 2014

    Report

    Report Number
    2032227-2014-16516
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: RELIABILITY ANALYSIS: INSPECTED 1 OPENED/USED ENLITE SENSOR AND PERFORMED BICARBONATE BUFFERTEST PER (B)(4). SENSOR FAILED PER SPEC DUE TO HIGH READINGS. SA (B)(6) 2014.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT'S INSULIN PUMP IS READING HIGHLY DIFFERENTIATED BLOOD GLUCOSE AND SENSOR GLUCOSE READINGS. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 149MG/DL. TROUBLE SHOOTING WAS CONDUCTED. DEVICE IS NOT BEING RETURNED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541394 SENSOR ENLITE MMT-7008A OZO OZO MEDTRONIC MINIMED MMT-7008A L193

    Patients

    Seq Age Sex Outcome Treatment
    1 114 YR