BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAL

    MDR report key: 11308128 · Received February 10, 2021

    Report

    Report Number
    2032227-2021-113406
    Event Type
    Injury
    Date Received
    February 10, 2021
    Date of Event
    October 2, 2018
    Report Date
    December 8, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000643169202375
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CRACKED DISPLAY WINDOW, SCRATCHED DISPLAY WINDOW, CRACKED RESERVOIR TUBE, SCRATCHED RESERVOIR TUBE WINDOW, MISSING END CAP STICKER AND CRACKED RESERVOIR TUBE LIP. THERE WAS NO BATTERY INSTALLED WHEN THE PUMP WAS RECEIVED. CUSTOMER BATTERY WAS RECEIVED WITH THE PACKAGING, DURACELL ALKALINE BATTERY AT 1.491 VOLTS. THE TEST ENERGIZER ALKALINE BATTERY IS 1.610 VOLTS. PARADIGM ANALYSIS SUMMARY: DEVICE PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, EXCESSIVE NO DELIVERY TEST AND DELIVERY ACCURACY TEST AT 0.08730 INCHES. THE STOP (IDLE) CURRENT AND RUN CURRENT MEASUREMENT TESTS ARE WITHIN SPECIFICATION. UNIT ALSO PASSED SELF TEST, OFF NO POWER ALARM TEST AND A21 ERROR TEST. DEVICE WAS UNABLE TO PRIME DURING THE PRIME/A33 TEST (SEATING AT 2.5 LBS.). DURING THE OCCLUSION TEST ON THE 1ST ATTEMPT, THE UNIT DELIVERED 7.0 UNITS. NO "NO DELIVERY ALARM" NOTED. THERE WAS NO LEAKS NOTED WHEN VISUALLY INSPECTING THE RESERVOIR/INFUSION SET. PERFORMED THE OCCLUSION TEST (2ND ATTEMPT), THE DEVICE ALARMED MOTOR ERROR AT 4.15 UNITS. THERE WAS ALSO A REST ALARM JUST PRIOR TO THE CARELINK UPLOAD PROCESS. UNABLE TO VERIFY PRIME ANOMALY, MOTOR ERROR ALARM AND RESET ALARM DUE TO INSULIN PUMP PRESERVATION. INFUSION SET TEST APPENDIX: PART/MODEL: UNKNOWN. MM BATCH NO.: UNKNOWN. REFERENCE NO.: UNKNOWN. LOT NO.: UNKNOWN. INFUSION SET VISUAL INSPECTION: TEST SAMPLE IS USED, 30 INCHES LONG. NO CRACK NOTED ON THE TUBING. UNKNOWN CLEAR SUBSTANCE NOTED INSIDE THE TUBING. CANNULA BENT. MEASUREMENTS: SAMPLE 1 FLOW RATE 48.0 SCCM (STANDARD CUBIC CENTIMETERS PER MINUTE) - PASS. INFUSION SET SUMMARY ANALYSIS: SAMPLE 1 PASSED THE INFUSION SET TESTING. 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

    MEDTRONIC LEGAL RECEIVED INFORMATION REGARDING JACK HAD BEEN USING THE PUMP AND INFUSION SET IN A REASONABLE AND FORESEEABLE MANNER. DURING THIS DAY, HE MANUALLY ENTERED THE NUMBER OF CARBOHYDRATES HE CONSUMED, AND THE MEDTRONIC PUMP CALCULATED AND ADMINISTERED A CORRESPONDING DOSE OF NOVO LOG INSULIN TO MATCH AS RESULT OF HIS SUDDEN AND UNANTICIPATED ONSET OF SYMPTOMS, JACK FELL 40-FEET DOWN THE CENTER OF A STAIRWELL, SUSTAINING A SEVER TRAUMATIC BRAIN INJURY AS WELL AS OTHER SEVERE, LIFE-ALTERING, AND PERMANENT INJURIES TO HIS SKULL, FACIAL BONES, FEMUR, HIPS, SHOULDERS, CARDIOVASCULAR SYSTEM, NERVOUS SYSTEM, AND MORE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203118 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAL PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL B1723NALJ 000000643169202375

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Unknown Other FRN-MMT-332-RSVR, UNOMED INF SET| FRN-MMT-332-RSVR, UNOMED INF SET