BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR,MMT-7002C,10PK,GLUCOSE,BSA,17L

    MDR report key: 2172462 · Received June 17, 2011

    Report

    Report Number
    2032227-2011-01477
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    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

    THE CUSTOMER REPORTED HAVING SIGNS OF SKIN INFECTION. THE CUSTOMER STATED THAT THE ELECTRODE IS IRRITATING HER SKIN AND LEAVING A SCAR AFTER IT IS REMOVED. THE CUSTOMER STATED THAT THE SITE OFTEN IS RED AND SWOLLEN. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THE SITE DID HAVE PUS. SENSOR WAS LOCATED IN LOWER ABDOMEN AREA. THE CUSTOMER STATED THAT SHE DID WEAR SENSOR FOR 6 DAYS ONCE, BUT HAS NOT DONE IT SINCE. REMINDED THE CUSTOMER THAT FDA APPROVED TO WEAR THE SENSOR FOR 3 DAYS AND SHOULD BE REMOVED AFTER THE THIRD DAY. SUGGESTED THE CUSTOMER TO TRY USING ALCOHOL TO CLEAN SKIN PRIOR TO INSERTION AND ADVISED THE CUSTOMER TO CONSULT WITH HER DOCTOR ABOUT ISSUE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSOR,MMT-7002C,10PK,GLUCOSE,BSA,17L GLUCOSE SENSOR (PRODUCT CODE MDS) MDS MEDTRONIC MINIMED MMT-7002C

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR