BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 13108838 · Received December 29, 2021

    Report

    Report Number
    2032227-2021-236734
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Date of Event
    December 28, 2021
    Report Date
    May 15, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. CUSTOMER RETURNED INSULIN PUMP FOR AN ALLEGED BLANK DISPLAY AND COSMETIC DAMAGE LOCATED AT THE BATTERY COMPARTMENT FOUND ON DEC 28, 2021. DEVICE WAS RECEIVED WITH A PARTIALLY BROKEN BATTERY TUBE THREADS AND A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT. DEVICE POWERED UP PROPERLY AFTER BATTERY INSTALLATION. DEVICE PASSED THE DISPLACEMENT TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELF TEST. DEVICE WAS MONITORED FOR SEVERAL HOURS AND NO BLANK DISPLAY NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPECIFICATION RANGE. NO ALARMS/ALERTS NOTED DURING THE TESTING. HOWEVER, LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 12/28/2021 09:20:01.000 REPLACE BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 12/28/2021 18:51:00.000. INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 12/28/2021 18:58:16.000 TO 12/28/2021 19:29:00.000 AND POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 12/28/2021 19:09:17.000, 12/28/2021 19:09:28.000, 12/28/2021 19:30:18.000. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, LOW BATTERY ALERT, REPLACE BATTERY ALERT AND POWER LOSS ALARM WAS EXPECTED SINCE THE BATTERY HAS LOW/NO POWER. THE CUSTOMER MAY HAVE USED A LOW/DEPLETED BATTERY. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND IT WAS VERIFIED THAT THE BATTERY TUBE POWER CONNECTOR IS PROPERLY CONNECTED TO J7/PCB1. NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY, A STAINED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY, A SCRATCHED CASE AND A SERIAL NUMBER LABEL MISSING, COSMETIC DAMAGE WAS CONFIRMED AT THE BATTERY COMPARTMENT. BLANK DISPLAY 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 · 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC STATED THAT THE INSULIN PUMP WAS NOT TURNING ON. CUSTOMER STATED THAT THE BATTERY COMPARTMENT WAS CRACKED. NO HARM WAS REQUIRED DURING MEDICAL INTERVENTION. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2013738 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG4DCVE 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male