BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1782K 670G V4.11 MM

    MDR report key: 12252442 · Received July 30, 2021

    Report

    Report Number
    2032227-2021-174628
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    July 20, 2021
    Report Date
    December 6, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000264727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSULIN PUMP WAS RETURNED FOR A BLANK DISPLAY AND COSMETIC DAMAGE LOCATED NEAR THE BATTERY COMPARTMENT FOUND ON (B)(6) 2021. DEVICE WAS RECEIVED WITH A CRACKED BATTERY TUBE THREADS. THE INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELF TEST. THE INSULIN PUMP 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 SPECIFIC RANGE. NO ALARMS OR ALERTS NOTED DURING THE TESTING. HOWEVER, LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 07/19/2021 18:41:00.000 ALARMALERTNOTIFICATION, 07/19/2021 21:04:56.000 ALARMALERTCLEARED, REPLACE BATTERY ALERT WAS RECORDED ON: (B)(6) 2021 04:12:00.000 ALARMALERTNOTIFICATION, REPLACE BATTERY NOW ALARM WAS RECORDED ON: (B)(6) 2021 04:43:00.000 ALARMALERTNOTIFICATION, (B)(6) 2021 04:53:00.000 ALARMALERTNOTIFICATION, POWER LOSS ALARM WAS RECORDED ON: (B)(6) 2021 10:03:56.000 ALARMALERTNOTIFICATION, 07/20/2021 10:04:02.000 ALARMALERTCLEARED, INSERT BATTERY ALARM WAS RECORDED ON: (B)(6) 2021 10:01:30.000 ALARMALERTNOTIFICATION, (B)(6) 2021 10:01:30.000 ALARMALERTNOTIFICATION, (B)(6) 2021 10:02:52.000 ALARMALERTNOTIFICATION, AND FAILED BATTERY/BATTERY FAILED ALARM WAS RECORDED ON: (B)(6) 2021 10:01:48.000 ALARMALERTNOTIFICATION, (B)(6) 2021 10:02:11.000 ALARMALERTNOTIFICATION, (B)(6) 2021 10:02:24.000 ALARMALERTCLEARED, (B)(6) 2021 10:02:32.000 ALARMALERTNOTIFICATION. UPON CHECKING ON THE DETAIL TRACE FILE, BATTERY ALARMS/ALERTS WERE EXPECTED SINCE THE BATTERY HAS LOW POWER. 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. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE, A CRACKED KEYPAD OVERLAY, A KEYPAD OVERLAY PEELING, A MISSING DISPLAY WINDOW/COVER, A PILLOWING KEYPAD OVERLAY AND A SERIAL NUMBER LABEL MISSING. COSMETIC DAMAGE WAS CONFIRMED NEAR THE BATTERY COMPARTMENT. BLANK DISPLAY 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 · 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

    IT WAS REPORTED THAT CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER BLOOD GLUCOSE LEVEL WAS 30.2 MMOL/L. IT WAS UNKNOWN THAT AUTO MODE FEATURE WAS ACTIVE AT THE TIME OF HIGH BLOOD GLUCOSE EVENT. CUSTOMER ALSO REPORTED CRACK NEAR BATTERY COMPARTMENT AND INSULIN PUMP STOPPED WORKING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153342 PUMP MMT-1782K 670G V4.11 MM ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782K HG46W52 000000763000264727

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other FRN-UNK-RSVR, UNOMED SET| FRN-UNK-RSVR, UNOMED SET