BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET DEVICE SNSRTR CMFRT EN

    MDR report key: 3942837 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04437
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    May 6, 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
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SERTER DEVICE WAS NOT RELEASING THE SENSORS AND THAT SHE INSERTED THEM MANUALLY. THE BLOOD GLUCOSE READING WAS 350 MG/DL. CUSTOMER TREATED THE HIGH BLOOD GLUCOSE WITH A BOLUS. CUSTOMER DECLINED TO TROUBLESHOOT THE INSULIN PUMP. SHE WAS ADVISED NOT TO PUSH HARD INTO THE BODY BETWEEN BUTTON PRESSES. CUSTOMER STATED THAT THE NEEDLE HUB ASSEMBLY RELEASED FROM THE SERTER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419950 LANCET DEVICE SNSRTR CMFRT EN CGM MDS MEDTRONIC MINIMED MMT-7510

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR