BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 9731334 · Received February 20, 2020

    Report

    Report Number
    3004209178-2020-72665
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Date of Event
    February 16, 2020
    Report Date
    February 1, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00763000192143
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 02/16/2020 THE CUSTOMER ALLEGED POWER LOSS ALARM, BLANK DISPLAY, AND COSMETIC DAMAGE(CRACKED BATTERY COMPARTMENT). THE TEST P-CAP LOCKS PROPERLY IN PLACE IN THE RESERVOIR COMPARTMENT NOTED. NO BLANK DISPLAY NOTED DURING TESTING. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR OR FORCE SENSOR. DEVICE RECEIVED WITH CRACKED RETAINER, PILLOWING KEYPAD OVERLAY, CRACKED CASE ON BATTERY TUBE, MISSING DISPLAY WINDOW/COVER, CRACKED CASE ABOVE ARROW AND BATTERY ICON, AND CRACKED BATTERY TUBE THREADS IDENTIFIED DURING THE VISUAL INSPECTION. THUS WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPECIFIC RANGE. IN FURTHER FULL REVIEW IN THE DEVICE HISTORY FOUND NO POWER LOSS ALARM ON THE EVENT DATE OF 02/16/2020 AT 02:21:29 AND 02:21:40; ALSO, FOUND: INSERT BATTERY ALARMS ON 02/16/2020 AT 02:04:35, 02:05:26, 02:06:50, 02:08:09, 02:08:59, 02:09:11, 02:10:26, AND 02:10:31. LOW BATTERY ALARMS ON 02/15/2020 AT 15:48:00 AND 15:48:13. ON 02/16/2020 AT 02:05:09, 02:09:42, 02:10:08, AND 02:10:22. REPLACE BATTERY ALARM ON 02/16/2020 AT 01:19:00. REPLACE BATTERY NOW ON 02/16/2020 AT 01:50:00 AND 02:00:00. FAILED BATTERY ALARM ON 02/16/2020 AT 02:04:46, 02:05:09, 02:05:51, 02:06:13, 02:06:28, 02:06:59, 02:07:22, 02:07:36, 02:07:46, 02:08:17, 02:08:39, 02:08:53, 02:09:19, 02:09:42, 02:10:08, AND 02:10:22. DEVICE PASSED SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND DISPLACEMENT TEST. NO UNEXPECTED LOW BATTERY ALARMS DURING TESTING. IN SUMMARY, INSULIN PUMP PASSED REQUIRED TESTING. CUSTOMER ALLEGED FOR POWER LOSS ALARM WAS NOT CONFIRMED. BLANK DISPLAY NOT CONFIRMED. CUSTOMER ALLEGATION FOR COSMETIC DAMAGE (CRACKED BATTERY COMPARTMENT) WAS CONFIRMED DURING VISUAL INSPECTION WHERE CRACKED CASE ON BATTERY TUBE AND CRACKED BATTERY TUBE THREADS WAS NOTED. 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. 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. 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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. CUSTOMER STATED THE DISPLAY WAS NOT BLANK LESS THAN 30 SECONDS. CUSTOMER STATED DISPLAY WAS BLANK CURRENTLY. CUSTOMER STATED THE CONTACTS ON THE BATTERY CAP WAS NEITHER MISSING NOR DAMAGED. CUSTOMER STATED BATTERY COMPARTMENT WAS DAMAGED. CUSTOMER STATES THE SPRING IS NEITHER DAMAGED NOR CORRODED. CUSTOMER REPORTED THAT THE DISPLAY DID NOT RETURN. CUSTOMER REPORTED THAT THE INSULIN PUMP NOT EXPOSED TO MOISTURE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195041 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG39TBE 00763000192143

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown