BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1714K 630G BLACK MMOL CANADA

    MDR report key: 17403764 · Received July 27, 2023

    Report

    Report Number
    2032227-2023-243742
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    July 7, 2023
    Report Date
    November 1, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000315702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER RETURNED PUMP FOR AN ALLEGED CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND PUMP 35 ALARM FOUND ON 07-JUL-2023. PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST AND SELF TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. SUCCESSFULLY UTILIZED CREST AND THUS TO DOWNLOAD HISTORY FILES, TRACES AND COMLINK3 FILES. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND PUMP ERROR 35 ALARM CONFIRMED IN THE FORMATTED HISTORY FILE ON 07/07/2023 19:47:00.000 AND 07/07/2023 19:57:00.000. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE PCBA 1, PCBA 2 AND FORCE SENSOR. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE MOTOR AND VIBRATOR ASSEMBLY NOTED. PERFORM BRUSH CLEANING WITH THE ISOPROPYL ALCOHOL THE MOISTURE DAMAGE AREAS AND REINSTALLED THE ORIGINAL ELECTRONICS, CASE, INTERNAL BATTERY AND MOTOR. THE CRITICAL PUMP ERROR OCCURRED DURING TESTING. IN CONCLUSION, CRITICAL PUMP ERROR (OPEN BOOK) AND PUMP ERROR 35 ALARM FOUND IN THE FORMATTED HISTORY FILE DUE TO CORROSION ON THE PCBA 1, PCBA 2 AND FORCE SENSOR. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 2 DAYS PRIOR TO THE EVENT DATE 07-JUL-2023 IN THE FORMATTED HISTORY FILE.  INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 07/07/2023 19:48:11.000, 07/07/2023 19:58:07.000, 07/07/2023 19:59:21.000, 07/07/2023 19:59:28.000, 07/07/2023 19:59:30.000. LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 07/07/2023 19:48:00.000, 07/07/2023 19:58:00.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 07/07/2023 19:59:27.000, 07/07/2023 19:59:29.000. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS EXPECTED DUE TO PUMP BATTERY DOES NOT HAVE ENOUGH POWER. THE CUSTOMER MAY HAVE USED A NO POWER/DEPLETED BATTERY. UPON CHECKING ON THE POWER DATA, LOW BATTERY ALERT UNLOADED VAA VOLTAGE (BATTERY VOLTAGE) IS 1.712V AND 1.667V. LOW BATTERY ALERT WAS UNEXPECTED SINCE THE CUSTOMER IS USING A GOOD BATTERY. UNABLE TO TEST FOR FAILED BATTERY ALERT/BATTERY FAILED ALARM AND LOW BATTERY ALERT DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. FAILED BATTERY ALERT/BATTERY FAILED ALARM AND LOW BATTERY ALERT WERE UNKNOWN. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT AND A SERIAL NUMBER LABEL FADING. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DUE TO FATAL ALARM PUMP ERROR 35. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND PUMP ERROR 35 ALARM CONFIRMED DUE TO CORROSION ON THE PCBA 1, PCBA 2 AND FORCE SENSOR. 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

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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 REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED OUTSIDE THE UNITED STATES. ¿SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS."" " 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER RECEIVED A PUMP ERROR 35- ¿¿A BROKEN FORCE SENSOR WAS DETECTED DURING SEATING OR REGULAR DELIVERY¿¿. TROUBLESHOOTING WAS PERFORMED, EXPLAINED THE PUMP PERFORMS SAFETY CHECKS AND AN ERROR WAS FOUND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637749 PUMP MMT-1714K 630G BLACK MMOL CANADA AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1714K HG5UMS5 000000763000315702

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Unknown