BEUDAMED
    FDA Adverse Event Injury Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 15913191 · Received December 5, 2022

    Report

    Report Number
    2032227-2022-369755
    Event Type
    Injury
    Date Received
    December 5, 2022
    Date of Event
    November 6, 2022
    Report Date
    December 28, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. CASE TYPE = NGP. CUSTOMER RETURNED INSULIN PUMP FOR AN ALLEGED REWIND ANOMALY, COSMETIC DAMAGE LOCATED AT THE CASE AND WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS FOUND ON (B)(6) 2022. THE INSULIN PUMP WAS RECEIVED WITH A SCRATCHED CASE AND A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT. THE 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 0.08730 INCHES. THE INSULIN PUMP REWIND, LOAD RESERVOIR AND NO RESERVOIR DETECTED ALARMS PROPERLY. THE INSULIN PUMP REWINDS SUCCESSFULLY. THE INSULIN PUMP WAS MONITORED AND NO REWIND ANOMALY NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY UPLOADED INSULIN PUMP TO CARELINK. NO INSULIN PUMP ERROR ALARM OR MOTOR RELATED ALARMS NOTED IN THE FORMATTED HISTORY FILE. ON (B)(6) 202219:51:00.000, RESERVOIR ESTIMATE 0 ALERT(113) WAS RECORDED IN THE FORMATTED HISTORY FILE. ON (B)(6), 202219:51:10.000, THE USER CLEARED THE ALARM. ON (B)(6) 202219:52:06.000, THE USER PERFORMED REWIND ON THE INSULIN PUMP. THERE WAS NO RECORD OF INSULIN PUMP REWIND IN THE FORMATTED HISTORY FILE FOR THE EVENT DATE OF (B)(6) 2022. INSULIN PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRICAL BOARD1, ELECTRICAL BOARD2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (22.4 MV). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A STAINED KEYPAD OVERLAY AND A SERIAL NUMBER LABEL FADING. COSMETIC DAMAGE WAS CONFIRMED AT THE INSULIN PUMP CASE. THE INSULIN PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS. THE FORCE SENSOR IS WITHIN SPECIFICATION AND THE MOTOR FUNCTIONING PROPERLY. REWIND ANOMALY 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. INITIAL REPORT WAS SUBMITTED WITH MISSING INFORMATION. THE CORRECTED INFORMATION HAS BEEN UPDATED AND PROVIDED WITH THIS REPORT IN SECTION B5. HEALTH EFFECT CLINICAL CODE HAS BEEN UPDATED AND PROVIDED WITH THIS REPORT IN SECTION H6.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA AND THE BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF THE EVENT. THE CUSTOMER WAS TREATED WITH HOSPITALIZATION AND THE CUSTOMER EXPERIENCED SHORTNESS OF BREATHING AND DIABETIC KETOACIDOSIS. TROUBLESHOOTING WAS PARTIALLY PERFORMED AND FOUND THAT THE INSULIN PUMP WAS USED WITHIN 48 HOURS. IT WAS UNKNOWN THAT THE AUTO MODE FEATURE WAS ACTIVE AT THE TIME OF THE EVENT. THE TROUBLESHOOTING WAS DECLINED BY THE CUSTOMER LATER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE INSULIN PUMP AND WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    THE DEVICE WAS RETURNED FOR THE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2577103 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG5N11Y 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Other FRN-MMT-332A-RSVR, UNOMED SET, OZP MMT-MMT-7020A-S.