BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1782K 670G V4.11 MM

    MDR report key: 12717521 · Received October 29, 2021

    Report

    Report Number
    2032227-2021-211985
    Event Type
    Injury
    Date Received
    October 29, 2021
    Date of Event
    October 21, 2021
    Report Date
    March 17, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000187422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = CLEAR. CUSTOMER RETURNED PUMP FOR AN ALLEGED REWIND ANOMALY AND WAS HOSPITALIZED FOR HIGH BGS FOUND ON (B)(6), 2021. THE PUMP PASSED THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08705 INCHES. THE PUMP WAS MONITORED FOR SEVERAL DAYS AND NO UNEXPECTED REWIND NOTED DURING THE TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY UPLOADED PUMP TO CARELINK. NO PUMP ERROR 37, 38, 39, 41, 42, 43, 79, 80, 82 AND 130 ALARM NOTED IN THE FORMATTED HISTORY FILE. AS PER CHECKING THE FORMATTED HISTORY FILE, NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM DURING PRIME AND BOLUS DELIVERY ON: (B)(6) 2021 00:05:49.000, (B)(6) 2021 02:02:00.000, (B)(6) 2021 02:59:01.000, (B)(6) 2021 05:05:23.000, (B)(6) 2021 05:39:00.000, (B)(6) 2021 08:46:00.000 AND (B)(6) 2021 16:37:00.000. THE USER CLEARS THE ALARM AND PERFORMED REWIND ON THE PUMP ON: (B)(6) 2021 00:06:03.000 , (B)(6) 2021 02:08:24.000 , (B)(6) 2021 02:59:19.000 , (B)(6) 2021 05:05:23.000 , (B)(6) 2021 05:41:06.000 , (B)(6) 2021 08:52:32.000. AND (B)(6) 2021 16:41:13.000. NO UNEXPECTED PUMP REWIND NOTED IN THE FORMATTED HISTORY FILE. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (22.2 MV). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. THE TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT. HOWEVER, A CRACKED RETAINER¿WAS NOTED DURING TESTING. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY, A STAINED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY, A KEYPAD OVERLAY TEXTURE DAMAGE AND A SCRATCHED CASE. A CRACKED RETAINER WAS CONFIRMED. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS. THE FORCE SENSOR IS WITHIN SPECIFICATION AND THE MOTOR FUNCTIONING PROPERLY. REWIND ANOMALY WAS NOT CONFIRMED. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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.

    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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH MAIL BY REPORTER THAT CUSTOMER WAS IN INTENSIVE CARE UNIT FOR UNKNOWN REASON. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS UNKNOWN. DATE OF HOSPITALIZATION WAS UNKNOWN. IT WAS REPORTED THAT INSULIN PUMP WAS REWIND MULTIPLE TIMES IN DAY WITHOUT CUSTOMER'S INTERFERENCE. IT WAS UNKNOWN THAT CUSTOMER WAS USING INSULIN PUMP OR NOT WITHIN 48 HOURS OF INCIDENT. IT WAS UNKNOWN THAT AUTO MODE FEATURE WAS ACTIVE OR NOT AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616070 PUMP MMT-1782K 670G V4.11 MM ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782K HG3CFGE 000000763000187422

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization FRN-UNK-RSVR, UNOMED SET.| FRN-UNK-RSVR, UNOMED SET.