BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP MMT-751NAL

    MDR report key: 7198191 · Received January 16, 2018

    Report

    Report Number
    3004209178-2018-43607
    Event Type
    Injury
    Date Received
    January 16, 2018
    Date of Event
    January 5, 2018
    Report Date
    January 16, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169503694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. 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

    COMPLAINTS TEXT (B)(6) 2018 10:23:26 (B)(4) INITIAL NOTES: CUSTOMER IS CALLING BACK TO CONT T/S FROM LAST NIGHT INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: CHANGE SENSOR CHANGE SENSOR ALERT (6 DAY) T/S PER DOP114-691. EXPL ALERT AND POSSIBLE CAUSES. CUSTOMER REPORTS CONSECUTIVE CHANGE SENSOR ALERTS WITH DIFFERENT SENSORS. CUSTOMER IS ABLE TO RUN THE TEST PLUG PROCEDURE. ASSISTED IN PERFORMING THE TEST PLUG PROCEDURE. TEST PASSED. ADV TO INSPECT SENSOR TO DETERMINE IF IT IS SECURELY TAPED TO SKIN OR IF IT HAS MOVED. FOUND: SECURE. OFFERED TO REVIEW SENSOR BEST PRACTICES (SITE SELECTION, TAPING, CALIBRATION PROTOCOL). CUSTOMER ACCEPTED REVIEW. ADV TO CHOOSE AN INSERTION SITE THAT HAS AN ADEQUATE AMOUNT OF SUB-Q FAT TISSUE. ADV SENSOR SHOULD BE AT LEAST 2 INCHES FROM NAVEL OR PUMP INFUSION SITE AND AT LEAST 3 INCHES AWAY FROM ANY MANUAL INJECTION SITE. ADV FOR BEST SENSOR PERFORMANCE AND TO AVOID ACCIDENTAL SENSOR REMOVAL TO AVOID INSERTING IN MUSCLE OR AREAS WITH TOUGH SKIN OR HARD TISSUE. ADV TO AVOID INSERTING IN SITES SUBJECTED TO RIGOROUS MOVEMENT DURING EXERCISE. ADV TO AVOID INSERTING IN AREAS CONSTRAINED BY CLOTHING OR ACCESSORIES SUCH AS SITES UNDER A BELT OR THE WAISTLINE. ADV CUSTOMER TO REMOVE AND CHANGE OUT THE SENSOR. EXPL THERE MAY BE A POSSIBLE ISSUE WITH THE SENSOR. ADV TO RETURN THE SENSOR. CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT: WILL REPL SENSORS SHIP: 3 MMT-7008B / RETURN: 3 MMT-7008A ____________________ COMPLAINTS TEXT (B)(6) 2018 00:15:17 ERP_RFC_USER RELATED (B)(4)____________________ COMPLAINTS TEXT (B)(6) 2018 00:07:12 ERP_RFC_USER RELATED (B)(4) ____________________ COMPLAINTS TEXT (B)(6) 2018 00:07:09 ERP_RFC_USER RELATED (B)(4) ____________________ COMPLAINTS TEXT (B)(6) 2018 00:00:59 (B)(4) INITIAL NOTES: PATIENT REPORTING 3 SENSORS THAT FAILED AFTER USING IT FOR 1 DAY AND A HALF. IT IS GETTING LOW READING ON THE SENSOR BG AT 45 MG/DL BUT UNABLE TO REMEMBER WHAT WAS HIS LOW BG LAST (B)(6) 2017. TREATED BUT READING DID NOT CAME BACK TO A GOOD LEVEL. 1ST SENSOR ¿ RECEIVED A LOW 65 MG/DL SG ALARM BUT WHEN HE CHECKED IT FROM THE METER 164 MG/DL (B)(6) 2018. INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: NO RELEVANT ACTIVITY THAT COULD CAUSE THE ISSUE. ENLITE SG VS BG RECURRING EVENTS T/S PER (B)(4). 1. DATE, TIME AND LOCATION OF INSERTION WAS: (B)(6) 2017 8:00 AM ABDOMEN. 2. SENSOR MATERIAL AND EXPIRATION DATE IS: MMT-7008 EXP: 2018 5 2. LOT # IS: HG23XLF. 3. ACTIVITY AT THE TIME OF THE REPORTED SG VS BG EVENT WAS: NO ACTIVITY. 4. VERIFIED SENSOR AGE IN STATUS SCREEN. FOUND: NA. 5. SERTER MATERIAL: MMT-7512NA. DESCRIPTION OF EVENTS: BG IS HIGHER THAN SG FOR 99 POINTS.. RECEIVED A LOW 65 MG/DL SG ALARM BUT WHEN HE CHECKED IT FROM THE METER 164 MG/DL (B)(6) 2018 THEN LATER IT WONT CALIBRATE AND FINALLY TOLD THE PATIENT TO CHANGE THE SENSOR. INQUIRED IF CUSTOMER EXPERIENCED SG VS BG EVENTS WITH MULTIPLE SENSORS. FOUND: YES. ADV CARELINK DATA WILL PROVIDE ADDITIONAL INFORMATION RELEVANT TO THE SG VS BG EVENTS. CUSTOMER REPORTS THEY ARE ABLE TO UPLOAD TO CARELINK. CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT: DUE TO THE UPLOAD THAT TOOK TIME. PATIENT DECIDED TO CALL IT A DAY FOR TS. ADVISED TO CALL BACK TOMORROW TO CONTINUE THE TS AND TO COMPLETE THE DOCUMENTATION AS WELL AS REPLACING THE DEFECTIVE SENSORS. ADDITIONAL NOTES: CURRENT BG IS 192 MG/DL ADVISED PATIENT TO UPLOAD TO CARELINK. OFFERED CALL BACK AFTER 5-10 MINUTES TO COMPLETE THE UPLOAD 1ST. PATIENT AGREED. WHEN CALLED BACK PATIENT HIS COMPUTER IS NOT WORKING PROPERLY FOR THE UPLOADS. ASSISTED PATIENT TO RUN INTERNET EXPLORER AS AN ADMINISTRATOR BROWSER. PATIENT STILL USING THE WHITE USB FOR UPLOAD. ASKED IF HE ALSO HAS THE BAYER CONTOUR LINK METER: YES. ADVISED TO USE ONLY THE METER. PUMP BATTERY IS OK AND NO TEMP BASAL RUNNING. ASSISTED PATIENT GO TO RECORD FOR FULL TEXT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42052 530G INSULIN PUMP MMT-751NAL ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL A4751NALJ 00643169503694

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other