BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANCET DEVICE MMT-7510 SNSRTR CMFRT EN

    MDR report key: 4170114 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37729
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS INSPECTED 1 OPENED/USED ENLITE SERTER AND PERFORMED INSTRUCTION TEST USING A NEW LAB ENLITE SENSOR ALONG WITH RUBBER SKIN. THE ENLITE SERTER PASSED PER SPECIFICATION. INSERT/RELEASE SENSOR PROPERLY.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE LEVELS IN THE 300'S AND 400'S MG/DL. EXACT BLOOD GLUCOSE LEVELS WERE NOT INCLUDED IN THE REPORT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649546 LANCET DEVICE MMT-7510 SNSRTR CMFRT EN CGM MDS MEDTRONIC MINIMED MMT-7510

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR