BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1781K 670G V4.11 MG

    MDR report key: 13103278 · Received December 29, 2021

    Report

    Report Number
    2032227-2021-236360
    Event Type
    Injury
    Date Received
    December 29, 2021
    Date of Event
    December 25, 2021
    Report Date
    June 27, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000187415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. ON DECEMBER 25, 2021 THE INSULIN PUMP WAS RETURNED DUE TO CUSTOMER ALLEGATION TO PUMP UNDER DELIVERING AND INSULIN FLOW BLACK ALARMS CAUSING HIGH BLOOD GLUCOSES. THE INSULIN PUMP PASSED ALL FUNCTIONAL TESTING INCLUDING THE SELF TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST, AND THE DELIVERY ACCURACY TEST AT 0.08710 INCHES. NO UNEXPECTED INSULIN FLOW BLOCKED ALARMS NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY UPLOADED TO CARELINK AND GENERATED REPORTS. NO UNDER DELIVERY ANOMALY NOTED DURING TESTING. INSULIN FLOW BLOCK ALARMS NOTED IN THE INSULIN PUMP HISTORY/TRACE FILES ON 12/25/2021 AT 16:04:00.000 DURING BASAL. IN FURTHER FULL REVIEW OF THE INSULIN PUMP HISTORY ON THE EVENT DATE OF DECEMBER 25, 2021 FOUND BOLUS DELIVERIES OF 4.8UNIT AT 00:58:50.000, 5.7UNIT AT 07:14:42.000, AND 24UNIT AT 20:48:46.000. FORCE SENSOR WAS MEASURED AND IS WITHIN SPECIFICATION (22.3MILIVOLT AT ZERO OFFSET). INSULIN PUMP 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 INSULIN PUMP WAS RECEIVED WITH SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED RETAINER RING, CRACKED CASE, CRACKED CASE(BATTERY TUBE), AND CRACKED BATTERY TUBE THREADS. INSULIN FLOW BLOCK ALARMS NOT CONFIRMED DURING TESTING. UNDER DELIVERING NOT CONFIRMED DURING FULL FUNCTIONAL TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BLOOD GLUCOSES. 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

    IT WAS REPORTED BY THE CUSTOMER THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. BLOOD GLUCOSE READING WAS 480 MG/DL. THE CUSTOMER STATED THAT THEY HAD INFUSION FLOW BLOCKED ALARMS PRIOR TO THE INCIDENT. THE CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. THE CUSTOMER WAS NOT USING AUTO MODE. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH INSULIN PEN. THE CUSTOMER DID THE TROUBLESHOOTING FOR HIGH READINGS AND INFUSION FLOW BLOCKED ALARM. THE INSULIN PUMP WELL BE RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2007763 PUMP MMT-1781K 670G V4.11 MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1781K HG36DQM 000000763000187415

    Patients

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