INSET
Report
- Report Number
- 3003442380-2026-00190
- Event Type
- Injury
- Date Received
- January 30, 2026
- Date of Event
- January 14, 2026
- Report Date
- February 18, 2026
- Manufacturer
- UNOMEDICAL UM-D
- 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
INITIAL AND FINAL MDR (B)(4). DEVICE 3 OF 3.
SUPPLEMENTAL REPORT 01- MDR (B)(4)- MDR 3003442380-2026-00190. 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 06-FEB-2026 AGAINST "LOT NUMBER 6012315 AND SIMILAR MALFUNCTION CODES: ADHESIVE PATCH DOES NOT ADHERE TO THE SKIN AFTER DIRECT APPLICATION, ADHESIVE PATCH DOES NOT ADHERE TO THE SKIN AT POINT OF APPLICATION (I.E., NOT STICKY, NO ATTACHMENT, OR A FEW MINUTES OF ATTACHMENT). REFER TO IF THE ADHESIVE PATCH LIFTS DURING USE. 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 06-FEB-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6012315 AND SIMILAR MALFUNCTION CODES: ADHESIVE PATCH DOES NOT ADHERE TO THE SKIN AFTER DIRECT APPLICATION, ADHESIVE PATCH DOES NOT ADHERE TO THE SKIN AT POINT OF APPLICATION (I.E., NOT STICKY, NO ATTACHMENT, OR A FEW MINUTES OF ATTACHMENT). REFER TO IF THE ADHESIVE PATCH LIFTS DURING USE. THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBERS ARE (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012315 WAS PACKAGING ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 121, IN THE 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 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 FOR THE REPORTED MALFUNCTION CODE ADHESIVE PATCH DOES NOT ADHERE TO THE SKIN AFTER DIRECT APPLICATION. ALL TEST RESULTS WERE WITHIN SPECIFICATION AS DOCUMENTED IN THE ATTACHED TEST REPORT COMPLAINT (B)(4). CONCLUSION: TESTING DID NOT CONFIRM THE REPORTED ISSUE; NO NONCONFORMANCE IDENTIFIED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: RETURN SAMPLES TESTING: AVAILABLE FOR RETURN. CONCLUSION: VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO LACK OF SAMPLE AVAILABILITY. ASSESSMENT WILL BE BASED ON OTHER AVAILABLE EVIDENCE. 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, 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. 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 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.
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) ON (B)(6) 2026 SINCE THE PATIENT FACED THREE INFUSION SET ADHESIVE ISSUES LEADING TO HYPERGLYCEMIA. THE BLOOD GLUCOSE LEVEL WAS 500 MG/DL AND ABOVE AT THE TIME OF THE EVENT, AND THE KETONE LEVEL WAS POSITIVE, INDICATING A DANGEROUS AND LIFE-THREATENING CONDITION. THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2026. THE LENGTH OF STAY IN THE EMERGENCY ROOM WAS SIX HOURS. THE PATIENT REPLACED THE INFUSION SET AND SUCCESSFULLY RESUMED INSULIN DELIVERIES. NO FURTHER INFORMATION AVAILABLE.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283352 | INSET | UNO INSET I 110/9 GREY TCAP 10PK INT | FPA | UNOMEDICAL UM-D | 1001729 | 6012315 | 05705244016958 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female | Life Threatening| R |