BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET DEVICE SNSRTR CMFRT EN

    MDR report key: 3942770 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04241
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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

    EVALUATED ONE OPENED AND USED ENLITE-SERTER. PERFORMED INSERTION TEST. ENLITE-SERTER PASSED PER SPECIFICATION. ENLITE-SERTER CONNECT AND RELEASE PROPERLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SERTER IS MALFUNCTIONING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 121 MG/DL. CUSTOMER STATED THAT THE LAST FOUR INSERTIONS SENSOR READINGS WERE OFF, ALSO NOTICED THEY WERE BENT WHEN REMOVED. CUSTOMER BELIEVES THAT THE SENSOR ISSUES WERE CORRELATED WITH HOW SHE INSERTS THE SENSOR. CUSTOMER ATTEMPTED TO PUT IN A NEW SENSOR, DEVICE DISLODGED WHEN SHE TRIED TO REMOVE THE SERTER. NEEDLE HUB WAS STUCK IN THE SERTER. INSTRUCTION PROVIDED IN HOW TO REMOVE THE NEEDLE HUB FROM SERTER. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419827 LANCET DEVICE SNSRTR CMFRT EN CGM MDS MEDTRONIC MINIMED MMT-7510

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR