BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR

    MDR report key: 4203115 · Received September 17, 2014

    Report

    Report Number
    2032227-2014-24360
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 17, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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/USED SENSOR AND PERFORMED VISUAL INSPECTION AND FOUND NO BROKEN PARTS IN THE SENSOR. ALSO CHECKED NEEDLE FOR BURRS/HOOKS AND DULL NEEDLES TIP DEFECTS AND NONE WERE FOUND. INTRODUCER NEEDLE PASSED PER SPECIFICATION. UNABLE TO CONFIRM THE CUSTOMER RECEIVED THE NEEDLE IN THAT CONDITION BECAUSE THE SENSOR WAS RETURNED OPENED/USED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HE COULD NOT GET THE NEEDLE OUT OF HIS SKIN AFTER MINUTES OF TUGGING, TWISTING, AND PULLING. CUSTOMER WAS ABLE TO REMOVE LATER. CUSTOMER'S BLOOD GLUCOSE WAS 109 MG/DL. CUSTOMER JUST WANTED A REPLACEMENT. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576090 SENSOR MDS MEDTRONIC MINIMED MMT-7002C E014

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR