BEUDAMED
    FDA Adverse Event Death Summary report: N

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    MDR report key: 11698932 · Received April 21, 2021

    Report

    Report Number
    2032227-2021-137538
    Event Type
    Death
    Date Received
    April 21, 2021
    Date of Event
    April 5, 2021
    Report Date
    February 17, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000316631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK . ON (B)(6) 2021 THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS. ON (B)(6) 2021 THE INSULIN PUMP WAS RETURNED DUE TO CUSTOMER PASSING AWAY. THE DEVICE DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. DEVICE PASSED THE FUNCTIONAL TEST, 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 THE DELIVERY ACCURACY TEST AT 0.0876 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY UPLOADED TO CARELINK AND GENERATED REPORTS. THE DEVICE P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. DEVICE HAD SCRATCHED CASE, SCRATCHED SERIAL NUMBER LABEL AND A PILLOWING KEYPAD OVERLAY. DATA ANALYSIS: (B)(6) 2021 DAILYTOTALOFALLINSULINDELIVERED = 48. (B)(6) 2021 DAILYTOTALOFALLINSULINDELIVERED = 47.45. (B)(6) 2021 DAILYTOTALOFALLINSULINDELIVERED = 47.95. (B)(6) 2021 DAILYTOTALOFALLINSULINDELIVERED = 48. (B)(6) 2021 DAILYTOTALOFALLINSULINDELIVERED = 48. (B)(6) 2021 DAILYTOTALOFALLINSULINDELIVERED = 48. (B)(6) 2021 DAILYTOTALOFALLINSULINDELIVERED = 48. (B)(6) 2021 DAILYTOTALOFALLINSULINDELIVERED = 7.55. (B)(6) 2021 DAILYTOTALOFALLINSULINDELIVERED = 0. (B)(6) 2021DAILYTOTALOFALLINSULINDELIVERED = 0. (B)(6) 2021 DAILYTOTALOFALLINSULINDELIVERED = 0. (B)(6) 2021 DAILYTOTALOFALLINSULINDELIVERED = 0. (B)(6) 2021 DAILYTOTALOFALLINSULINDELIVERED = 0. (B)(6) 2021 DAILYTOTALOFALLINSULINDELIVERED = 0. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS. NO DEVICE PROBLEM FOUND DURING FULL FUNCTIONAL TESTING. 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

    DEVICE DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. DEVICE PASSED THE FUNCTIONAL TEST, 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 THE DELIVERY ACCURACY TEST AT 0.0876 INCHES. DEVICE UPLOADED PROPERLY USING CARE LINK. DEVICE HAD SCRATCHED CASE, SCRATCHED SERIAL NUMBER LABEL AND A PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. (B)(4).

    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 VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY IN HOSPITAL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2021 DUE TO HIGH BLOOD GLUCOSE. THE CAUSE OF DEATH WAS PNEUMONIA, COVID 19, HEART AND KIDNEY FAILURE, AS WELL AS DIABETES KETOACIDOSIS. THE CALLER STATED THAT THE CUSTOMER HAD PNEUMONIA, COVID 19, PLUS HEART AND KIDNEY FAILURE THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS 578 MG/DL AT THE TIME OF ADMISSION, AND IN THE LOW TO MID 200 MG/DL RANGE AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE INSULIN PUMP HAD BEEN DISCONNECTED MORE THAN 48 HOURS PRIOR TO PASSING, AT THE TIME OF ADMISSION. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER STATED THE CUSTOMER'S BLOOD GLUCOSE WAS UNCONTROLLED, HAD HEART AND KIDNEY FAILURE, AND GOT COVID PNEUMONIA AND WAS IN THE HOSPITAL FOR THAT. THE CUSTOMER'S PARENT HAD TAKEN CARE OF THE CUSTOMER FOR 4 WEEKS BEFORE SHE PASSED. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599162 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG44ECC 000000763000316631

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Hospitalization| D FRN-UNK-RSVR| FRN-UNK-RSVR