BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELT CLIP MMT-640CL PUMP CLEAR

    MDR report key: 3930804 · Received July 12, 2014

    Report

    Report Number
    2032227-2014-03711
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BEING UNABLE TO CLIP ON HER INSULIN PUMP DUE TO BELT CLIP BROKEN. SHE ALSO REPORTED SHE EXPERIENCED LOW BLOOD GLUCOSE. SHE STATED HER BLOOD GLUCOSE LEVEL WAS 40MG/DL. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408577 BELT CLIP MMT-640CL PUMP CLEAR CGM MDS MEDTRONIC MINIMED MMT-640CL

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR