BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 15656935 · Received October 24, 2022

    Report

    Report Number
    2032227-2022-351711
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    October 4, 2022
    Report Date
    December 25, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    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. CUSTOMER RETURNED PUMP FOR AN ALLEGED BLANK DISPLAY, FAILED BATTERY TEST ALARM AND COSMETIC DAMAGE AT THE SERIAL NUMBER LABEL ON OCTOBER 4, 2022. THE TEST BATTERY WAS REMOVED AND REINSERTED WITH NO FAILED BATTERY TEST ALARM NOTED. THE PUMP PASSED THE DISPLACEMENT TEST, ACTIVE CURRENT TEST, SLEEP CURRENT TEST AND SELF TEST. NO BLANK DISPLAY NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. THE FAILED BATTERY TEST ALARM WAS EXPECTED DUE TO THE CUSTOMER'S LOW BATTERY VOLTAGE PER POWER MANAGEMENT REPORT. THERE WAS MULTIPLE FAILED BATTERY TEST ALARM LISTED ON THE EVENT DATE OCTOBER 4, 2022 IN THE PUMP HISTORY FILE. PLEASE SEE BELOW THE FIRST 8 FAILED BATTERY TEST ALARM LISTED ON THE EVENT DATE OCTOBER 4, 2022 IN THE PUMP HISTORY FILE. OCTOBER 4, 202215:35:31.000 ALARM ALERT NOTIFICATION FAULT NUMBER = FAILED BATT TEST (58) OCTOBER 4, 202215:35:51.000 ALARM ALERT NOTIFICATION FAULT NUMBER = FAILED BATT TEST (58) OCTOBER 4, 202215:46:27.000 ALARM ALERT NOTIFICATION FAULT NUMBER = FAILED BATT TEST (58) OCTOBER 4, 202215:46:31.000 ALARM ALERT NOTIFICATION FAULT NUMBER = FAILED BATT TEST (58) OCTOBER 4, 202215:46:35.000 ALARM ALERT NOTIFICATION FAULT NUMBER = FAILED BATT TEST (58) OCTOBER 4, 202215:46:39.000 ALARM ALERT NOTIFICATION FAULT NUMBER = FAILED BATT TEST (58) OCTOBER 4, 202215:46:43.000 ALARM ALERT NOTIFICATION FAULT NUMBER = FAILED BATT TEST (58) OCTOBER 4, 202215:46:47.000 ALARM ALERT NOTIFICATION FAULT NUMBER = FAILED BATT TEST (58) THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. NO PUMP ERROR 25, LOW BATTERY ALERT, POWER LOSS ALARM, REPLACE BATTERY ALERT OR REPLACE BATTERY NOW ALARM NOTED DURING TESTING. NO PUMP ERROR 25, NOTED IN THE PUMP TRACE DOWNLOAD. THERE WAS LOW BATTERY ALERT, POWER LOSS ALARM, REPLACE BATTERY ALERT, OR REPLACE BATTERY NOW ALARM NOTED IN THE PUMP TRACE DOWNLOAD. NO UNEXPECTED LOW BATTERY ALERT, POWER LOSS ALARM/BATTERY OUT LIMIT ALARM, REPLACE BATTERY ALERT, OR REPLACE BATTERY NOW ALARM NOTED. AUGUST 23, 202202:03:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = LOW BATTERY ALERT(104) OCTOBER 4, 202205:56:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = LOW BATTERY ALERT(104) APRIL 24, 2022 01:25:08.000 ALARM ALERT NOTIFICATION FAULT NUMBER = BATT OUT LIMIT(6) OCTOBER 4, 202216:14:31.000 ALARM ALERT NOTIFICATION FAULT NUMBER = BATT OUT LIMIT(6) AUGUST 23, 202211:44:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = CHANGE BATTERY FAULT (73) OCTOBER 4, 202215:27:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = CHANGE BATTERY FAULT (73) OCTOBER 4, 202215:58:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = OFF NO POWER (11) THE PUMP WAS RECEIVED WITH A MISSING SERIAL NUMBER LABEL. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR/DEEP SCRATCHED DISPLAY WINDOW, SCRATCHED DISPLAY WINDOW COVER, SCRATCHED CASE, CRACKED BATTERY TUBE THREADS, CRACKED CASE AT THE BATTERY TUBE SIDE, CRACKED CASE AT CORNER OF THE BELT CLIP RAIL, PILLOWING KEYPAD OVERLAY AND SCRATCHED KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS BLANK DISPLAY WAS NOT OBSERVED DURING ANALYSIS AND PASSED ALL REQUIRED TESTING. BLANK DISPLAY NOT CONFIRMED. FAILED BATTERY TEST ALARM NOT CONFIRMED. COSMETIC DAMAGE WAS CONFIRMED AT BACK OF THE PUMP (MISSING SERIAL NUMBER LABEL). 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

    (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. 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

    THE DEVICE WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT CUSTOMER TRIED MULTIPLE BATTERIES AND KEEP GETTING INSERT BATTERY ALARM AFTER SOMETIME CUSTOMER RECEIVED BATTERY FAILED ALERT. THE SCREEN WENT BLANK AGAIN. CUSTOMER MENTIONED PUMP SERIAL NUMBER WAS WORN ON THE BACK OF THE PUMP, BUT WAS ABLE TO READ IT CORRECTLY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED, CUSTOMER REPORTED CUSTOMER WAS ABLE TO CLEAR THE ALARM AND THE ISSUE WAS NOT RESOLVED. THE CUSTOMER WILL DISCONTINUE USE OF THE DEVICE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2805177 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG4JYWH 000000763000365882

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female