INSET
Report
- Report Number
- 3003442380-2026-00386
- Event Type
- Injury
- Date Received
- February 10, 2026
- Date of Event
- January 14, 2026
- Report Date
- March 11, 2026
- Manufacturer
- UNOMEDICAL DEVICES S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 05705244016958
- PMA / PMN Number
- K032854
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
SUPPLEMENTAL REPORT (B)(4) MDR 3003442380-2026-00386. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED COMMON DEVICE NAME UNDER D2, MODEL NUMBER, SERIAL NUMBER, PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER UNDER D4. 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 10-MAR-2026 AGAINST "LOT NUMBER 6012315 AND SIMILAR MALFUNCTION CODES: COMPONENT DEFECT- MALFUNCTION CODE NOT ON LIST. INFUSION SET BROKEN, DAMAGED, OR DEFECTIVE. PRIOR TO USE. (E.G., FOUND A FAILURE DIRECTLY IN THE PACKAGE). THE REVIEW CONFIRMED THAT LOT 6012315 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 10-MAR-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6012315 AND SIMILAR MALFUNCTION CODES COMPONENT DEFECT- MALFUNCTION CODE NOT ON LIST. INFUSION SET BROKEN, DAMAGED, OR DEFECTIVE. PRIOR TO USE. (E.G., FOUND A FAILURE DIRECTLY IN THE PACKAGE). THE COUNT OF COMPLAINT IS (B)(4). THE COMPLAINT NUMBERS ARE (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012315 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 121 AND MANUFACTURED IN THE INSET LINE 05 ON 14-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED IN ACCORDANCE WITH APPLICABLE PROCEDURES. ALL REQUIRED IN-PROCESS AND FINAL TESTS WERE COMPLETED AND MET SPECIFIED REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED THAT RELATE TO THE COMPLAINT CODE. CONCLUSION: DHR REVIEW SUPPORTS COMPLIANCE WITH MANUFACTURING AND QUALITY REQUIREMENTS; NO ISSUES NOTED. VISUAL EVIDENCE REVIEW: NO PHOTO WAS PROVIDED TO SUPPORT VISUAL CONFIRMATION OF THE REPORTED ISSUE. CONCLUSION: UNABLE TO PERFORM VISUAL VERIFICATION; ASSESSMENT BASED ON AVAILABLE DOCUMENTATION ONLY. RETAIN SAMPLES TESTING: RETAIN SAMPLES FROM THE RELEVANT LOT WERE PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 08-FEB-2026. WI GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3: 3 SAMPLES OUT 3 TESTED PASSED VISUAL INSPECTION TESTING FOR THE REPORTED MALFUNCTION CODE COMPONENT DEFECT- MALFUNCTION CODE NOT ON LIST. CONCLUSION: TESTING DID NOT CONFIRM THE REPORTED ISSUE; NO NONCONFORMANCE IDENTIFIED. 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). 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, VISUAL EVIDENCE ASSESSMENT, AND CAPA DETERMINATION. NO NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE WERE FOUND FOR LOT 6012315 AND RELATED MALFUNCTION CODES. (B)(4) 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 NOTED. SAMPLES WERE REQUESTED; HOWEVER, THE CUSTOMER CONFIRMED THAT NO SAMPLES WERE AVAILABLE FOR ANALYSIS. CONSEQUENTLY, AN INVESTIGATION WAS CONDUCTED USING REFERENCE SAMPLES, AND NO FAILURES RELATED TO THE COMPLAINT WERE IDENTIFIED. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION AND REFERENCE SAMPLE ANALYSIS ONLY. BASED ON THESE RESULTS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH ROUTINE TRACKING AND TRENDING.
INITIAL AND FINAL MDR (B)(4) DEVICE 1 OF 4.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED NEEDLE ISSUES AND TUBING WOULD NOT UNWIND FROM INFUSION SET INSERTION DEVICE ON (B)(6) 2026 DUE TO WHICH THE PATIENT FACED HYPERGLYCEMIA EVENT. THE PATIENT WENT TO EMERGENCY ROOM AND DURATION OF STAY WAS FOR 6 HOURS. THE BLOOD GLUCOSE LEVEL WAS ABOVE 500 MG/DL AND THE PATIENT WAS TREATED WITH INTRAVENOUS AND FLUIDS OF SALINE AND INSULIN. THE PATIENT WAS TESTED POSITIVE FOR KETONES AND IT WAS SERIOUS AND LIFE THREATENING. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2026. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. THE ISSUE OCCURED WITH 4 INFUSION SETS. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 350221 | INSET | UNO INSET I 110/9 GREY TCAP 10PK INT | FPA | UNOMEDICAL DEVICES S.A. DE C.V. | 1001729 | 6012315 | 05705244016958 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female | Life Threatening| R |