BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET DEVICE SNSRTR CMFRT EN

    MDR report key: 3930710 · Received July 12, 2014

    Report

    Report Number
    2032227-2014-03731
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 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 AND USED ENLITE-SERTER. PERFORMED INSERTION TEST. ENLITE-SERTER PASSED PER SPECIFICATION. ENLITE-SERTER CONNECTED AND RELEASED PROPERLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SERTER DOES NOT RELEASE THE SENSOR AFTER THE SECOND BUTTON PRESS. CUSTOMER STATED SHE IS UNSURE IF THE CATCH ARM MAY HAVE BEEN PRESSED OR PUSHED. SHE STATED THAT THE NEEDLE HUB IS STUCK IN THE SERTER. SHE STATED THAT THE SENSOR WAS DISLODGED FROM THE SKIN AS THE SERTER WAS REMOVED FROM THE BODY. CUSTOMER WAS ADVISED TO HOLD THE BUTTON IN AND GENTLY SHAKE THE SENSOR TO REMOVE THE NEEDLE HUB ASSEMBLY. CUSTOMER STATED THAT THE NEEDLE HUB ASSEMBLY WAS RELEASED FROM THE SERTER. THE BLOOD GLUCOSE READING WAS 127 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408738 LANCET DEVICE SNSRTR CMFRT EN CGM MDS MEDTRONIC MINIMED MMT-7510

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR