BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1715KM 630G 3ML BLACK MEDI  

    MDR report key: 12567110 · Received October 4, 2021

    Report

    Report Number
    2032227-2021-200549
    Event Type
    Injury
    Date Received
    October 4, 2021
    Date of Event
    June 25, 2021
    Report Date
    May 26, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000643169873834
    Removal / Correction Number
    Z-0955-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = CLEAR. CUSTOMER HOSPITALIZATION REPORTED ON (B)(6), 2021 FOR DIABETIC KETOACIDOSIS. CUSTOMER ALLEGES THE KEYPAD BUTTONS ARE NOT RESPONDING. THE TEST P-CAP LOCKS PROPERLY IN PLACE IN THE RESERVOIR COMPARTMENT NOTED. INSULIN PUMP RECEIVED WITH CRACKED RETAINER, CRACKED SELECT BUTTON KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, CRACKED CASE CORNER OF THE BELT CLIP RAILS NEAR THE BATTERY COMPARTMENT AND BROKEN BATTERY TUBE THREADS DURING THE VISUAL INSPECTION. THUS AND CARELINK SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. INSULIN PUMP PASSED THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DELIVERY ACCURACY TEST AT 0.08720 INCHES. ALL BUTTONS FUNCTIONING PROPERLY. THE KEYPAD OVERLAY WAS PEELED OFF, REMOVE THE KEYPAD DOME SWITCHES TO PERFORM THE KEYPAD TEST AND PASSED. NO MOISTURE OR COMPONENT DAMAGE ON THE KEYPAD TRACES OR KEYPAD DOMES DURING THE VISUAL INSPECTION. INSULIN PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO MOISTURE OR COMPONENT DAMAGE ON THE ELECTRONICS, FORCE SENSOR AND MOTOR ASSEMBLY NOTED. THE FORCE SENSOR OFFSET MEASURED WITHIN SPECIFICATION RANGE DURING TESTING (23.3 MILLI VOLT). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. INSULIN PUMP TESTED OK WITH NO DEVICE PROBLEM FOUND. TEST ANALYSIS INDICATES KEYPAD UNRESPONSIVE IS NOT CONFIRMED. UNABLE TO VERIFY CUSTOMER ALLEGED FOR DIABETIC KETOACIDOSIS. 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

    THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. UPDATED H9: Z-0955-2020. 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

    THE TEST P-CAP LOCKS PROPERLY IN PLACE IN THE RESERVOIR COMPARTMENT NOTED. DEVICE RECEIVED WITH CRACKED RETAINER, CRACKED SELECT BUTTON KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, CRACKED CASE CORNER OF THE BELT CLIP RAILS NEAR THE BATTERY COMPARTMENT AND BROKEN BATTERY TUBE THREADS DURING THE VISUAL INSPECTION. THUS AND CARELINK SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. DEVICE PASSED THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DELIVERY ACCURACY TEST. ALL BUTTONS FUNCTIONING PROPERLY. THE KEYPAD OVERLAY WAS PEELED OFF, REMOVE THE KEYPAD DOME SWITCHES TO PERFORM THE KEYPAD TEST AND PASSED. NO MOISTURE OR COMPONENT DAMAGE ON THE KEYPAD TRACES OR KEYPAD DOMES DURING THE VISUAL INSPECTION. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO MOISTURE OR COMPONENT DAMAGE ON THE ELECTRONICS, FORCE SENSOR AND MOTOR ASSEMBLY NOTED. THE FORCE SENSOR OFFSET MEASURED WITHIN SPECIFIC RANGE DURING TESTING (23.3 MILIVOLTS). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NEXT GENERATION INSULIN PUMP STB3 AND PASSED.

    Additional Manufacturer Narrative · 0

    RETAINER RING = CLEAR. CUSTOMER HOSPITALIZATION REPORTED ON (B)(6) 2021 FOR DIABETIC KETOACIDOSIS. CUSTOMER ALLEGES THE KEYPAD BUTTONS ARE NOT RESPONDING. THE TEST P-CAP LOCKS PROPERLY IN PLACE IN THE RESERVOIR COMPARTMENT NOTED. DEVICE RECEIVED WITH CRACKED RETAINER, CRACKED SELECT BUTTON KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, CRACKED CASE CORNER OF THE BELT CLIP RAILS NEAR THE BATTERY COMPARTMENT AND BROKEN BATTERY TUBE THREADS DURING THE VISUAL INSPECTION. THUS AND CARELINK SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. DEVICE PASSED THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DELIVERY ACCURACY TEST AT 0.08720 INCHES. ALL BUTTONS FUNCTIONING PROPERLY. THE KEYPAD OVERLAY WAS PEELED OFF, REMOVE THE KEYPAD DOME SWITCHES TO PERFORM THE KEYPAD TEST AND PASSED. NO MOISTURE OR COMPONENT DAMAGE ON THE KEYPAD TRACES OR KEYPAD DOMES DURING THE VISUAL INSPECTION. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO MOISTURE OR COMPONENT DAMAGE ON THE ELECTRONICS, FORCE SENSOR AND MOTOR ASSEMBLY NOTED. THE FORCE SENSOR OFFSET MEASURED WITHIN SPECIFICATION RANGE DURING TESTING. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. DEVICE TESTED OK WITH NO DEVICE PROBLEM FOUND. CUSTOMER ALLEGED BUTTONS DID NOT RESPOND TO INPUTS. TEST ANALYSIS INDICATES KEYPAD UNRESPONSIVE/BUTTON ERROR ALARM IS NOT CONFIRMED.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS ON (B)(6) 2021. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 367 MG/DL AT TIME OF INCIDENT. THE CUSTOMER STATED THAT THEY HAD HIGH BLOOD GLUCOSE AND THEY WAS TREATED WITH INSULIN DRIP. THE CUSTOMER STATED THAT THE SYMPTOMS RELATED TO HIGH BLOOD GLUCOSE SUCH AS VOMITING. IT WAS UNKNOWN CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465312 PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KM HG2FRE7 000000643169873834

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Hospitalization FRN-UNK-RSVR,UNOMED-SET| FRN-UNK-RSVR,UNOMED-SET