BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR MMT-7020A ENLITE3 5PK US

    MDR report key: 7581311 · Received June 8, 2018

    Report

    Report Number
    2032227-2018-04708
    Event Type
    Injury
    Date Received
    June 8, 2018
    Date of Event
    May 12, 2018
    Report Date
    June 7, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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.

    Description of Event or Problem · 1

    COMPLAINTS TEXT (B)(6) 2018 13:52:17 ERP_RFC_USER RELATED SVN (B)(4)____________________ COMPLAINTS TEXT (B)(6) 2018 13:52:14 ERP_RFC_USER RELATED SVN (B)(4) ____________________ COMPLAINTS TEXT (B)(6) 2018 13:51:28 (B)(6) INITIAL NOTES: CUSTOMER STATED HE RECEIVED A SENSOR UPDATING ALARM (B)(6) (B)(6) LB INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: CUSTOMER IS CALLING TO REPORT LOW BLOOD GLUCOSE EVENT SENSOR UPDATING (GUARDIAN SENSOR 3) T/S PER DOP114-980. EXPLAINED ALARM AND POSSIBLE CAUSES. VERIFIED ALERT IN PUMP'S HISTORY/DISPLAY. DATE, TIME AND LOCATION OF INSERTION WAS: (B)(6) ABDOMEN RIGHT. ACTIVITY AT THE TIME OF THE ALERT WAS: WALKING. SENSOR AGE (TIME LEFT). FOUND: UNKNOWN. SERTER MATERIAL: MMT-7512NA . SENSOR MATERIAL AND EXPIRATION DATE IS: UNKNOWN . LOT # IS: UNKNOWN . ITEM - 'EXPLAIN SENSOR CAN REQUIRE MORE TIME TO STABILIZE' REASON NOT COMPLETED - CUSTOMER HAD BEEN WEARING SENSOR FOR TWO . ADV ISIG <6NA MAY BE CAUSED BY AN INCORRECTLY INSERTED SENSOR OR A SENSOR DAMAGED DURING INSERTION. ADV ISIG >200NA MAY BE CAUSED BY MOISTURE ENTERING THE SENSOR CONNECTION OR AN INCORRECTLY INSERTED SENSOR. ADV LARGE SHIFTS OF THE ISIGS CAN BE CAUSED BY MOISTURE, A SENSOR DAMAGED DURING INSERTION, OR SENSOR PULL OUT. EXPLAIN SYSTEM DIAGNOSTICS MAY HAVE DETECTED SENSOR IS NOT PROPERLY RESPONDING TO GLUCOSE AND STOPPED DISPLAYING GLUCOSE READINGS. ADV TO INSPECT SENSOR TO DETERMINE IF IT IS SECURELY TAPED TO SKIN OR IF IT HAS MOVED. FOUND: YES. OFFERED TO REVIEW SENSOR BEST PRACTICES (SITE SELECTION, TAPING, CALIBRATION PROTOCOL). CUSTOMER DECLINED TO REVIEW. EXPLAINED SENSOR UPDATING STATUS OR ALERT MAY PERSIST FOR UP TO 3 HOURS BUT MOST RESOLVE IN A SHORTER PERIOD. ADV THAT WITHIN, OR AT, 3 HOURS THE SYSTEM WILL EITHER DISPLAY SG VALUES, ASK FOR A CALIBRATION, OR ALARM WITH CHANGE SENSOR. CUSTOMER HAS BEEN EXPERIENCING BEHAVIOR FOR LESS THAN 3 HOURS. ITEM - 'INSTRUCT CUSTOMER TO MONITOR THE PUMP AS SYSTEM MAY RECOVER AND TO CALL BACK IF FURTHER ASSISTANCE IS NEEDED' REASON NOT COMPLETED - CUSTOMER RECEIVED CHANGE . ITEM - 'ADVISE CUSTOMER THEY CAN DECIDE TO REPLACE SENSOR IF ISSUE RECURS' REASON NOT COMPLETED - ADVISED TO REPLACE . CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT: SENDING REPLACEMENT SENSOR 1 MMT-7020B 1 CAN-SM-LE SHIP: 1 MMT-7020B 1 CAN-SM-LE / RETURN: 1 MMT-7020B REASON FOR RETURN: ANALYSIS ____________________ COMPLAINTS TEXT (B)(6) 2018 13:50:27 (B)(6) INITIAL NOTES: CUSTOMER STATES HE RECEIVED TWO CAL NOT ACCEPTED 41BG SECOND CAL NOT ACCEPTED 45BG (B)(6) LB INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: CUSTOMER IS CALLING TO REPORT TWO CAL NOT ACCEPTED WHICH LEAD TO CHANGE SENSOR CALIBRATION NOT ACCEPTED (GUARDIAN SENSOR 3) T/S PER DOP114-980. EXPLAINED ALARM AND POSSIBLE CAUSES. VERIFIED ALERT IN PUMP'S HISTORY/DISPLAY. DATE, TIME AND LOCATION OF INSERTION WAS: (B)(6) ABDOMEN RIGHT. ACTIVITY AT THE TIME OF THE ALERT WAS: WALKING. SENSOR AGE (TIME LEFT). FOUND: UNKNOWN. SERTER MATERIAL: MMT-7512NA. SENSOR MATERIAL AND EXPIRATION DATE IS: UNKNOWN . LOT # IS: UNKNOWN . ADV TO INSPECT SENSOR TO DETERMINE IF IT IS SECURELY TAPED TO SKIN OR IF IT HAS MOVED. FOUND: NO CUSTOMER STATES HE WAS SWEATING. CUSTOMER RECEIVED A CHANGE SENSOR ALERT AFTER A CALIBRATION NOT ACCEPTED. ADV IF WAITING AT LEAST 15 MINUTES BEFORE ATTEMPTING CALIBRATION IS NOT SUCCESSFUL TO WAIT ONE HOUR FROM WHEN BG VALUE THAT RESULTED IN CALIBRATION NOT ACCEPTED WAS ENTERED BEFORE ENTERING A NEW BG FOR CALIBRATION. OFFERED TO REVIEW SENSOR BEST PRACTICES (SITE SELECTION, TAPING, CALIBRATION PROTOCOL). CUSTOMER DECLINED TO REVIEW. ADV TO RETURN THE SENSOR. CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT: SENDING REPLACEMENT SENSOR SHIP: NOTHING / RETURN: NOTHING ____________________ COMPLAINTS TEXT(B)(6)/ GO TO RECORD FOR FULL TEXT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424991 SENSOR MMT-7020A ENLITE3 5PK US ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7020A

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other