BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3ML MMT-332A

    MDR report key: 8235865 · Received January 10, 2019

    Report

    Report Number
    3004209178-2019-43502
    Event Type
    Injury
    Date Received
    January 10, 2019
    Date of Event
    December 6, 2018
    Report Date
    January 10, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    UDI-DI
    00643169786554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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

    ON (B)(6) 2018, (B)(6); COMPLAINT: (B)(4); COMPLAINT STATUS: IN PROCESS; MDT INITIAL CONTACT: (B)(6); INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: PUMP GAVE 13U OF INSULIN FOR NO REASON. CALCULATED BG WAS REAL HIGH. BG 15 CORRECTION OF 1.025. WHEN ASLEEP 9:02 5.525 AT 21:23 BG 33.3 BUT NO FINGERPRICK AND 2 MIN LATER 17.3. 21:25 GOT DOSE OF 7U AND WHEN WE CHECKED HER FINGER BG WAS 33.3 TO 2.4. LOW BG/OVER DELIVERY T/S PER (B)(4). PATIENT'S BG AT TIME OF INCIDENT: 2.4 MMOL/L. PATIENT'S CURRENT BG: 7.0 MMOL/L. PATIENT HAS BEEN EXPERIENCING LOW BGS FOR (B)(6) 2018. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BG EVENT. NGP MODEL PUMP CURRENTLY IN USE: 640G. CUSTOMER WAS NEITHER IN ER, NOR ADMITTED INTO HOSPITAL, NOR WAS EMS DISPATCHED AS A RESULT OF LOW BG. BASED ON CUSTOMER REPORT PROCEEDING IN T/S PER CUSTOMER ALLEGING POSSIBLE PUMP OVER DELIVERY. REASONS WHY CUSTOMER ALLEGES PUMP IS OVER DELIVERING: IT'S SHOWING TWO BOLUSES THAT THEY DID NOT PROGRAM. CUSTOMER ACTIONS PRIOR TO THE EVENT: WAS ASLEEP. TIME FRAME OF THE EVENT: 9 PM. LINKED METER USAGE: (B)(4). INQUIRED IF CUSTOMER RECEIVED ASSISTANCE WITH PROGRAMMING PUMP. FOUND: HAVE HAD PUMP FOR 18 MONTHS. NO CHANGES TO SETTINGS. CUSTOMER STATES THE MOST RECENT SET CHANGE WAS: (B)(6) 2018. MATERIAL NUMBER OF THE INFUSION SET IN USE AT THE TIME OF EVENT: MMT-921. LOT NUMBER OF THE INFUSION SET IN USE AT THE TIME OF EVENT: 5191358. MATERIAL NUMBER OF THE RESERVOIR IN USE AT THE TIME OF EVENT: MMT-332A. LOT NUMBER OF THE RESERVOIR IN USE AT THE TIME OF EVENT: HG2AP8L. INQUIRED IF DURING THE LAST SET CHANGE CUSTOMER RECALLS INSULIN DRIPPING OR SQUIRTING FROM END OF SET BEFORE CONNECTING AT THEIR SITE. FOUND: NO INSULIN SQUIRTING. THE PATIENT WAS DISCONNECTED DURING THE REWIND/PRIME SEQUENCE. INQUIRED IF INSULIN TYPE AND CONCENTRATION IS CORRECT BASED ON HCP GUIDANCE. CUSTOMER RESPONSE: U100. ADV TO D/C FROM SET AND REMOVE THE RES FROM THE PUMP. ADV TO CHECK THE STATUS SCREEN AND THEN VISUALLY INSPECT THE RES. RESERVOIR IS SHOWING THE SAME AMOUNT OF INSULIN AS SHOWN ON THE STATUS SCREEN. ITEM - 'REVIEW PUMP PROGRAMMING' REASON NOT COMPLETED - STATED PROGRAMMING WAS CORRECT. CUSTOMER REPORTS PROGRAMMING IS ACCURATE. REVIEWED HEALTH/LIFESTYLE ISSUES TO VERIFY IF CUSTOMER HAS HAD ANY UNUSUAL EVENTS. FOUND: UNRECOGNIZED BOLUSES. CUSTOMER REPORTS PUMP WAS NOT WORN DURING A MEDICAL PROCEDURE/TEST AROUND AN MRI. ADV TO AVOID EXPOSURE TO ANY STRONG MAGNETIC FIELDS ASSOCIATED WITH MRIS. BASED ON CUSTOMER REPORT PROCEEDING IN T/S PER CUSTOMER ALLEGING POSSIBLE PUMP OVER DELIVERY. CUSTOMER IS UNABLE TO UPLOAD TO CARELINK AT THIS TIME. ADV THE PUMP WILL NEED TO BE REPLACED. ADV TO DISCONTINUE USE OF THE PUMP. RECOMMENDED CUSTOMER REFER TO BACK UP PLAN, PER HCP INSTRUCTIONS. ADV TO RETURN SET/RESERVOIR AS CURRENTLY ASSEMBLED. ADV TO COMPLETE CARELINK UPLOAD BEFORE PUMP RETURN IF POSSIBLE AND TO CALL FOR ASSISTANCE WITH UPLOAD IF NEEDED. ADV TO PLACE THE PUMP IN STORAGE MODE: REMOVE BATTERY, PRESS AND HOLD THE BACK BUTTON UNTIL THE SCREEN TURNS OFF. EXPLAINED THE RPL POLICY. ADV TO MONITOR BGS UNTIL REPLACEMENT ARRIVES. CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT: ADVISED CUSTOMER THAT WE'LL SEND REQUEST TO LOCAL OFFICE FOR REPLACEMENT PUMP. LET HIM KNOW THAT THEY'LL FOLLOW UP WITH THEM ABOUT REPLACEMENT OPTIONS. SHIP: 1 PUMP/ RETURN: 1 PUMP COUNTRY: (B)(6). INPUT DATE: (B)(6) 2018; BATCH - HG2AP8L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27961 RESERVOIR 3ML MMT-332A PUMP, INFUSION FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG2AP8L 00643169786554

    Patients

    Seq Age Sex Outcome Treatment
    1 Other