INSET II
Report
- Report Number
- 3003442380-2026-04412
- Event Type
- Injury
- Date Received
- March 30, 2026
- Date of Event
- February 28, 2026
- Report Date
- March 2, 2026
- Manufacturer
- UNOMEDICAL DEVICES S.A. DE C.V.
- Product Code
- FPA
- PMA / PMN Number
- K032854
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY. COMPLAINT INVESTIGATION RESULTS: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 18/MAR/2026 AGAINST "LOT NUMBER" "6013678" AND SIMILAR MALFUNCTION CODES: LACK OF EFFECT- PROBLEMS ASSOCIATED WITH A PRODUCT HAVING LESS EFFICACY THAN EXPECTED. THE REVIEW CONFIRMED THAT LOT 6013678 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NONCONFORMING REPORTS (NCR)S OR CORRECTIVE AND PREVENTIVE ACTION (CAPA)S OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 18/MAR/2026 AGAINST "LOT NUMBER" CRITERIA EQUAL "6013678" AND SIMILAR MALFUNCTION CODES: LACK OF EFFECT- PROBLEMS ASSOCIATED WITH A PRODUCT HAVING LESS EFFICACY THAN EXPECTED. THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBERS ARE (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013678 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 78 AND MANUFACTURED IN LINE 5, ON 11/JUN/2025 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 5E02290 WAS MANUFACTURED ACCORDING TO THE WI VERSION 68 AND MANUFACTURED IN THE MACHINE SC09, ON 19/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 5E02291 WAS MANUFACTURED ACCORDING TO THE WI VERSION 68 AND MANUFACTURED IN THE MACHINE SC02, ON 10/JUN/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 5E02589 WAS MANUFACTURED ACCORDING TO THE WI VERSION 68 AND MANUFACTURED IN THE MACHINE SC09, ON 11/JUN/2025, WITH A TOTAL OF (B)(4) UNITS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT ALL REQUIRED IN PROCESS INSPECTIONS AND FINAL PRODUCT TESTS WERE COMPLETED. DURING OUTGOING TEST 6, ONE SAMPLE WAS IDENTIFIED WITH A CAP CONTAINING GREASE; HOWEVER, AN EXTENDED SAMPLING WAS PERFORMED IN ACCORDANCE WITH ESTABLISHED PROCEDURES, AND THE RESULTS MET THE SPECIFIED ACCEPTANCE CRITERIA. ADDITIONALLY, AN EXTENDED SAMPLING WAS ALSO PERFORMED FOR TYVEK MISALIGNMENT, WHICH WAS DOCUMENTED IN ACCORDANCE WITH ESTABLISHED PROCEDURES, AND THE RESULTS LIKEWISE MET THE SPECIFIED ACCEPTANCE CRITERIA. NO DEVIATIONS, NONCONFORMANCES (NC), OR EQUIPMENT RELATED MAINTENANCE EVENTS WERE IDENTIFIED THAT CORRELATE WITH THE REPORTED COMPLAINT CONDITION. CONCLUSION: THE DHR REVIEW CONFIRMED THAT ALL REQUIRED INSPECTIONS AND TESTS WERE COMPLETED. ALTHOUGH ISOLATED FINDINGS SUCH AS A CAP WITH GREASE AND TYVEK MISALIGNMENT WERE OBSERVED, EXTENDED SAMPLING MET ALL ACCEPTANCE CRITERIA. NO DEVIATIONS, NONCONFORMANCES, OR EQUIPMENT RELATED EVENTS WERE IDENTIFIED THAT CORRELATE WITH THE REPORTED COMPLAINT. NO MANUFACTURING FACTORS WERE FOUND TO BE ASSOCIATED WITH THE ISSUE. RETAIN SAMPLES TESTING: RETAIN SAMPLES FROM THE RELEVANT LOT WERE REQUESTED AND TESTED IN ACCORDANCE WITH APPROVED PROCEDURES: WI GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA (VERSION 3): ALL 3 SAMPLES TESTED PASSED VISUAL INSPECTION. WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA (VERSION 2): ALL 3 SAMPLES TESTED PASSED FUNCTIONAL AIR FLOW AND LEAKAGE TESTING FOR THE REPORTED MALFUNCTION CODE LACK OF EFFECT- PROBLEMS ASSOCIATED WITH A PRODUCT HAVING LESS EFFICACY THAN EXPECTED. ALL TEST RESULTS WERE WITHIN SPECIFICATION AS DOCUMENTED IN THE ATTACHED TEST REPORT COMPLAINT (B)(4) TEST REPORT. CONCLUSION: TESTING DID NOT CONFIRM THE REPORTED ISSUE; NO NONCONFORMANCE IDENTIFIED. CAPA DETERMINATION ASSESSMENT -CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: BASED ON THE INVESTIGATION, NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WI (MONTHLY TRIPS AND ALERTS). COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION, THE REPORTED FAILURE COULD NOT BE CONFIRMED FOR THIS COMPLAINT. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION AS A RESULT OF THE FOLLOWING A COMPREHENSIVE REVIEW WAS CONDUCTED, INCLUDING EQMS QUERIES, SIMILAR COMPLAINT SEARCHES, DEVICE HISTORY RECORD REVIEW, AND CAPA DETERMINATION. NO NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE WERE IDENTIFIED FOR LOT 6013678 OR RELATED MALFUNCTION CODES. ONE COMPLAINT WAS IDENTIFIED FOR THIS LOT; HOWEVER, NO TREND OR SYSTEMIC ISSUE WAS DETECTED. THE MANUFACTURING RECORDS CONFIRMED THAT THE LOT WAS PRODUCED IN COMPLIANCE WITH ALL REQUIREMENTS, WITH NO DEVIATIONS OR MAINTENANCE EVENTS RECORDED. AN INVESTIGATION WAS CONDUCTED USING REFERENCE SAMPLES, AND NO FAILURES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. BASED ON THE AVAILABLE DOCUMENTATION AND SAMPLE ANALYSIS, NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH ROUTINE TRACKING AND TRENDING.
REFERENCE NUMBER (B)(4) EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) ON (B)(6) 2026 AS THE BLOOD GLUCOSE LEVEL REACHED 600 MG/DL. DURING HOSPITALIZATION, THE PATIENT RECEIVED INSULIN VIA A SYRINGE PUMP AND 6-7 LITERS OF FLUIDS AND KETONES WERE TESTED. THE PATIENT WAS TRANSFERRED BACK TO A REGULAR WARD ON (B)(6) 2026. AT THE TIME OF THIS REPORT, THE PATIENT WAS ADMINISTERING INJECTIONS WITH A PEN. NO ADDITIONAL INFORMATION AVAILABLE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 774438 | INSET II | UNO INSET II 60/6 GREY Y-CAP 10PAK INT | FPA | UNOMEDICAL DEVICES S.A. DE C.V. | 86-060-52B6 | 6013678 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H |