BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4811589 · Received June 2, 2015

    Report

    Report Number
    2032227-2015-17684
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 14, 2015
    Report Date
    May 15, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS INSPECTED ONE OPENED/USED ENLITE SENSOR AND PERFORMED BICARBONATE BUFFER TEST. THE SENSOR FAILED PER SPECIFICATIONS DUE TO HIGH READINGS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THEIR BLOOD GLUCOSE READINGS WERE HIGH. THE INSULIN PUMP WILL BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356342 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR