BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 12356638 · Received August 23, 2021

    Report

    Report Number
    2032227-2021-183666
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    August 9, 2021
    Report Date
    August 23, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    SVN: (B)(4) START DATE OF THE SENSOR: (B)(6) 2021. START HOUR OF THE SENSOR: SENSOR START MISSING REASON: LOCATION OF SENSOR INSERTION: ABDOMEN. DATE OF SENSOR ALERT: (B)(6) 2021. HOUR OF SENSOR ALERT: SENSOR ALERT MISSING REASON: CRM SERVICE NOTIFICATION TEXT ON (B)(6) 2021, 08:30:31. ERP_RFC_USER RELATED SVN (B)(4) ____________________ CRM SERVICE NOTIFICATION TEXT ON (B)(6) 2021, 08:20:32. ERP_RFC_USER RELATED SVN (B)(4) ____________________ CRM SERVICE NOTIFICATION TEXT ON (B)(6) 2021, 08:15:57. ERP_RFC_USER RELATED SVN (B)(4) ____________________ CRM SERVICE NOTIFICATION TEXT ON (B)(6) 2021, 08:15:54. ERP_RFC_USER RELATED SVN (B)(4) ____________________ CRM SERVICE NOTIFICATION TEXT ON (B)(6) 2021, 08:15:19. (B)(6). CUSTOMER CONCERN: CUST IS REQUESTING THREE REPLACEMENT SENSORS. SHE INSERTED ALL THREE OF THE SENSORS YESTERDAY. WITH ALL THREE OF THE SENSORS, SHE EXPERIENCED SENSOR UPDATING FOLLOWED A CHANGE SENSOR ALERT. THE CUST MENTIONED THAT SHE BEGAN TO BLEED WHEN INSERTING THE SECOND SENSOR. SHE WAS EXPERIENCING A HIGH BG 205 YESTERDAY. (B)(4): CHANGE SENSOR/SENSOR UPDATING/SG VALUE NOT AVAILABLE/CALIBRATION NOT ACCEPTED. DOCUMENT SYSTEM MODEL NUMBER: 670G. DOCUMENT TRANSMITTER MODEL: MMT-7811. WOULD CUSTOMER LIKE TO CONTINUE TROUBLESHOOTING TO REVIEW FACTORS THAT MAY LEAD TO SENSOR ALERT?: YES. REVIEW CUSTOMER¿S ACCOUNT. IS THIS THE 2ND CALL ON THE SAME SENSOR OR HAS THE CUSTOMER CALLED WITHIN THE LAST 30 DAYS REGARDING SIMILAR ALERT?: NO. DID CUSTOMER RECEIVE ¿CHANGE SENSOR¿ ALERT?: YES. EXPLAIN POSSIBLE CAUSES OF CHANGE SENSOR ALERT. DID CUSTOMER RECEIVE ¿SENSOR UPDATING/SG VALUE NOT AVAILABLE¿ ALERT?: YES. EXPLAIN SENSOR UPDATING/SG VALUE NOT AVAILABLE ALERT AND POSSIBLE CAUSES. DID CUSTOMER RECEIVE ¿CALIBRATION NOT ACCEPTED¿ ALERT?: NO. ADVISE CUSTOMER TO INSPECT SENSOR TO DETERMINE IF IT IS SECURELY TAPED TO SKIN OR IF IT HAS MOVED. IS SENSOR SECURELY TAPED TO SKIN AND IS STILL IN PLACE?: YES. IS CUSTOMER CALLING TO REPORT CONSECUTIVE (BACK TO BACK) SENSOR ALERTS WITH DIFFERENT SENSORS?: YES. CAN CUSTOMER RUN A TEST ON TRANSMITTER?: YES. ASSIST CUSTOMER IN PERFORMING TEST ON TRANSMITTER: YES. WHAT IS RESULT OF THE TEST PROCEDURE?: TEST PASSED. OFFER TO REVIEW SENSOR BEST PRACTICES (SITE SELECTION, TAPING, CALIBRATION PROTOCOL). DOES CUSTOMER WISH TO REVIEW ANY OF THESE ITEMS?: NO. IS NON-SERIALIZED PRODUCT BEING REPLACED?: YES. DOCUMENT REPLACEMENT MMT# AND QUANTITY: 3 MMT-7020B. IS NON-SERIALIZED PRODUCT BEING RETURNED?: NO. (B)(4): TESTER PROCEDURE FOR TRANSMITTER DOCUMENT SYSTEM MODEL NUMBER: 670G. DOCUMENT TRANSMITTER MODEL: MMT-7811. ADVISE CUSTOMER TO UNPLUG THE TRANSMITTER FROM THE SENSOR. IS CUSTOMER CALLING BACK AFTER FULLY CHARGING THE TRANSMITTER (UP TO 2 HRS)?: NO. CHECK THE CONNECTOR PINS/BRIDGE ON TRANSMITTER FOR DAMAGE: NO. DAMAGE IS THE SENSOR FEATURE ON OR OFF?: ON. ASSIST CUSTOMER IN TURNING THE SENSOR FEATURE OFF AND ON. ADVISE CUSTOMER TO CONNECT THE TESTER AND WATCH FOR THE GREEN LED TO BLINK SEVERAL TIMES ON THE TRANSMITTER. DID THE LED BLINK ON AND OFF SEVERAL TIMES?: NO. LED TAKES UP TO 20 SECONDS TO BEGIN FLASHING. EMPHASIZE IMPORTANCE OF WATCHING THE LED AFTER CONNECTING. ADVISE CUSTOMER TO DISCONNECT THE TRANSMITTER AND ATTACH IT TO THE CHARGER . ADVISE TO CHARGE THE TRANSMITTER FOR ONE MINUTE. DID TRANSMITTER LED LIGHT BLINK ON AND OFF WHEN DISCONNECTED FROM THE CHARGER?: YES. ADVISE CUSTOMER TO WAIT 10 SECONDS BEFORE CONNECTING TRANSMITTER TO TESTER. ADVISE CUSTOMER TO CONNECT THE TESTER AND WATCH FOR THE GREEN LED TO BLINK SEVERAL TIMES ON THE TRANSMITTER. DID THE LED BLINK ON AND OFF FOR TEN SECONDS?: YES. GO TO THE ¿SENSOR CONNECTIONS¿ MENU AND SELECT ¿RECONNECT SENSOR¿. DID RF ICON TURN GREEN?: YES. TRANSMITTER IS WORKING CORRECTLY. REMOVE TESTER AND CONNECT TRANSMITTER TO THE SENSOR . WAS TESTER PROCEDURE REQUIRED AS PART OF TROUBLESHOOTING A SENSOR ALERT?: YES. (B)(4): SITE ISSUES DOCUMENT THE LOCATION, SIZE AND SHAPE OF THE SITE ISSUE: STOMACH. DOCUMENT DESCRIPTION OF THE SITE ISSUE: BLOOD AT SITE. IS CUSTOMER REPORTING A SKIN ISSUE ASSOCIATED WITH PRODUCT INSERTION SITE?: YES. IS CUSTOMER REPORTING BRUISING, HEMATOMA, BLOOD AT SITE?: YES. IS THE SITE ACTIVELY BLEEDING AT THE TIME OF CALL?: NO. EXPLAIN POSSIBLE CAUSE OF BLOOD AT SITE IS THAT PRODUCT MAY HAVE BEEN INSERTED IN A CAPILLARY/BLOOD VESSEL. WOULD CUSTOMER LIKE TO CONTINUE TROUBLESHOOTING SITE ISSUE(S)?: NO. IS NON-SERIALIZED PRODUCT BEING REPLACED?: YES. DOCUMENT REPLACEMENT MMT# AND QUANTITY: 3 MMT-7020B. IS NON-SERIALIZED PRODUCT BEING RETURNED?: NO. (B)(4): HIGH BGS/UNDER DELIVERY T/S EXIT REASON: CUSTOMER DECLINED/UNABLE TO T/S. IS ANY PRODUCT REPLACEMENT/RETURN NEEDED?: CONSUMABLE PRODUCT. IS NON-SERIALIZED PRODUCT BEING REPLACED?: YES. DOCUMENT REPLACEMENT MMT# AND QUANTITY: 3 MMT-7020B. IS NON-SERIALIZED PRODUCT BEING RETURNED?: NO. ADDITIONAL NOTES: PER SUP APPROVAL, THE CUST WILL RECEIVE THREE RPL SENSORS AS A ONE TIME COURTESY. THE CUST WAS NOT AWARE OF OUR POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253857 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG4T3P2 000000763000365882

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR