BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET DEVICE

    MDR report key: 3930860 · Received July 12, 2014

    Report

    Report Number
    2032227-2014-03641
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURN 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 1 OPENED AND USED ENLITE-SERTER. PERFORMED INSERTION TEST USING A NEW ENLITE SENSOR AND RUBBER SKIN. ENLITE-SERTER PASSED THE TEST ACCORDING TO SPECIFICATIONS. ENLITE-SERTER CONNECTS AND RELEASES PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS 119 MG/DL. CALLER STATED THAT THE SERTER WAS NOT WORKING CORRECTLY, THE SENSOR GOT STUCK IN THE SERTER AND THE SENSOR DID NOT INSERTED IN CUSTOMER'S BODY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408591 LANCET DEVICE CGM MDS MEDTRONIC MINIMED MMT-7510

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR