BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYSENTRY MONITOR KIT

    MDR report key: 4153150 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-35478
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    July 31, 2014
    Report Date
    October 3, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MY SENTRY MONITOR WAS RETURNED DUE TO IT STATED THAT OUTPOST AND MONITOR WERE UNABLE TO LINK. NO OTHER DETAILS GIVEN. BASED ON INFORMATION OF NOTIFICATION SERVICE THE SERIAL NUMBER OF THE RETURNED PRODUCT IS CONSISTENT AND MATCHES WITH PRODUCT RECEIVED. IN ACCORDANCE WITH DOP (B)(4), THE MONITOR WAS VISUAL INSPECTION IN CONDITION OF ITS RETURN. NO ANOMALIES WERE NOTED AND IT WAS LIGHTED UP NORMAL WHEN CONNECTED INTO WALL OUTLET THEN UNIT WAS SET TO LINK TO A GOOD FUNCTION MONITOR AND PUMP MMT-723NAS, SERIAL NUMBER (B)(4) RESULTING IN YOUR MONITOR AND OUTPOST ARE NOW LINKED. LINK IS SUCCESSFUL. REPEAT LINK STEP WITH 25 FEET AWAY FROM MONITOR. LINK STILL ESTABLISH WELL. THE OUTPOST WAS FUNCTIONING PROPERLY DURING THE ANALYSIS.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MYSENTRY MONITOR KIT HAS A WEAK SIGNAL EVERY ONCE IN A WHILE. ASSISTANCE WAS PROVIDED TO THE CUSTOMER. CUSTOMER'S BLOOD GLUCOSE WAS 46 MG/DL. ATTEMPTED TO TROUBLESHOOT, UNABLE TO DETERMINE WHY THE INSULIN PUMP KEPT LOSING SIGNAL 30 FEET WAY FROM THE MONITOR AND WHILE OUTPORT WAS 15 FT AWAY FROM MONITOR. ADVISED THE CUSTOMER THAT THE MYSENTRY MONITOR KIT WOULD BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631762 MYSENTRY MONITOR KIT CGM MDS MEDTRONIC MINIMED MMT-9102 TEMPBATCH

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR