BEUDAMED
    FDA Adverse Event Injury Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 11955687 · Received June 8, 2021

    Report

    Report Number
    2032227-2021-153949
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    May 1, 2019
    Report Date
    September 21, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000166526
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    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. INFORMATION HAS BEEN CORRECTED WHICH WAS NOT CORRECT IN THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN SECTION B2 WITH THIS REPORT. IN ADDITION TO THAT, FOLLOWING CORRECTIONS WERE ALSO DONE WITH THIS REPORT.1. CHANGED CASE SEVERITY FROM MALFUNCTION TO SERIOUS INJURY IN H1 TAB2. REMOVED HARM CODES 2515 FROM HEALTH EFFECT - CLINICAL CODE IN H6 TAB AS THE CODE DOES NOT APPLY TO THIS EVENT.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION: DETACHED AND BROKEN RETAINER RING, CRACKED/BROKEN RESERVOIR TUBE LIP, MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, RECEIVED WITH AMAZON BASIC ALKALINE BATTERY INSTALLED AT 0.031 VOLTS. THE TEST ENERGIZER ALKALINE BATTERY IS 1.590 VOLTS. NOTES: THE PUMP DID NOT POWER UP AFTER THE TEST BATTERY WAS INSTALLED. USING THE BATTERY SIMULATOR, THE PUMP POWERED ON. SET THE TIME AND DATE. PUMP WAS ABLE TO POWER ON USING THE TEST ENERGIZER ALKALINE BATTERY. CORRODED BATTERY CAP CONTACT WAS NOTED DURING VISUAL INSPECTION. RETAINER RING COLOR (BLACK OR CLEAR): CLEAR. IS THE RETAINER RING CONNECTED TO THE CASE (YES OR NO): NO. IS THE RETAINER RING INTACT (YES OR NO): NO. IF NO, DESCRIBE THE CONDITION: DETACHED AND BROKEN RETAINER RING, RECEIVED TAPED TO A WHITE NAPKIN. VERIFY IF THE RETAINER LOCKS IN PLACE? (YES OR NO): NO. THE PUMP PASSED THE FUNCTIONAL TEST, 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 THE DAT AT 0.0871 INCHES. CORRODED BATTERY CAP CONTACT (ORIGINAL BATTERY CAP) WAS THE CAUSE FOR FAILED BATTERY TEST ALARM AFTER THE ACTIVE CURRENT MEASUREMENT TEST WHILE INSTALLING THE TEST ENERGIZER ALKALINE BATTERY. TEST BATTERY VOLTAGE WAS 1.384 VOLTS. A TEST BATTERY CAP WAS USED TO POWER UP THE PUMP. THE PUMP POWERED UP PROPERLY WITH NO UNEXPECTED FAILED BATTERY TEST ALARM NOTED DURING TESTING. THE PUMP PASSED THE FUNCTIONAL TEST DURING LEGAL TESTING. DETACHED AND DAMAGED/BROKEN RETAINER RING CONFIRMED. RESERVOIR UNABLE TO LOCK INTO PLACE CONFIRMED. CORRODED BATTERY CAP CONTACT WAS NOTED DURING VISUAL INSPECTION. 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. 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

    CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP MALFUNCTIONED DUE TO A CRACKED RETAINER RING FAILED TO DELIVER CORRECT DOSE OF INSULIN TO THE CUSTOMER. CUSTOMER REPORTED SUFFERING FROM HYPOGLYCEMIA, SHAKINESS LIGHT HEADNESS AND CONFUSION AND LEFT SIDE FACIAL DROPPING. CUSTOMER HAD TO PAY OUT OF POCKET EXPENSES BECAUSE MEDTRONIC REFUSED TO PAY. IT WAS UNKNOWN IF AUTO MODE FEATURE WAS IN USE AT THE TIME OF THE EVENT. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853605 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG3H483 000000763000166526

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Hospitalization| O FRN-MMT-332-RSVR, UNOMED INF SET| FRN-MMT-332-RSVR, UNOMED INF SET