BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE MMT-7008A

    MDR report key: 6904221 · Received September 29, 2017

    Report

    Report Number
    2032227-2017-54316
    Event Type
    Malfunction
    Date Received
    September 29, 2017
    Date of Event
    September 24, 2017
    Report Date
    May 16, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    20643169646432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED/USED SENSOR AND PERFORMED CONTINUITY RESISTANCE TEST AND SENSOR FAILED PER SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. LAST NIGHT SHE STARTED GETTING MULTIPLE THRESHOLD SUSPENDS. THE CUSTOMER¿S BLOOD GLUCOSE WAS 143-146 MG/DL MG/DL AND THE SENSOR GLUCOSE WAS 70 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. SENSOR HAS BEEN IN USE LESS THAN OR EQUAL TO 3 DAYS AND STATED THAT THE SENSOR IS NOT GOING TO RECOVER. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686050 SENSOR ENLITE MMT-7008A ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-7008A HG1XY56 20643169646432

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR