MINIMED SILHOUETTE
Report
- Report Number
- 3003442380-2025-11365
- Event Type
- Malfunction
- Date Received
- July 8, 2025
- Date of Event
- June 15, 2025
- Report Date
- March 25, 2026
- Manufacturer
- UNOMEDICAL DEVICES S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 05705244019584
- PMA / PMN Number
- K162812
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: D9: DEVICE AVAILABLE FOR EVALUATION HAS BEEN SELECTED AS YES & DATE RETURNED TO MFG WAS ADDED AS WELL. H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY: THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6010318 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2 FOR THE LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS (REFERS TO CONNECTORS IN BOTH ENDS OF THE TUBING) PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1: AIR FLOW ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. FUNCTIONAL TEST 2: AIR LEAK ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. SEE ATTACHMENT DATABASE COMPLAINT (B)(4) COMPLAINT TEST REPORT FOR THE DETAILS. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010318 WAS MANUFACTURED ACCORDING TO THE WI VERSION 20 AND PACKAGING IN THE MACHINE 14, ON 28/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING: THE LOT 4L02427 WAS GLUED ACCORDING TO THE WI VERSION 15, LINE INSPECTION FOR MACHINE LC01 ON 27-NOV-2024, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 4L01183 WAS GLUED ACCORDING TO THE WI VERSION 34, LINE INSPECTION FOR MACHINE LC01 ON 17-NOV-2024, WITH A TOTAL OF (B)(4) UNITS EACH. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 12/AUG/2025 AGAINST MALFUNCTION CODE AND LOT 6010318 AND THREE MORE COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. THIS COMPLAINT WAS PREVIOUSLY INVESTIGATED ON 12-AUG-2025. THE INITIAL INVESTIGATION REMAINS VALID AND HAS NOT BEEN MODIFIED. HOWEVER, ADDITIONAL INFORMATION HAS BEEN INCORPORATED TO ALIGN THE CASE WITH THE CURRENT INVESTIGATION REQUIREMENTS COMPLAINT INVESTIGATION RESULTS - SUPPLEMENTAL INFORMATION: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 20/MAR/2026 AGAINST "LOT NUMBER" 6010318 AND SIMILAR MALFUNCTION CODES: TUBING DAMAGE - MINOR / LOCALIZED. TUBING IS SPLIT (ALONG THE LENGTH OF THE TUBING) OR HAS PINHOLES. THE REVIEW CONFIRMED THAT LOT 6010318 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 19-MAR-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6010318 AND SIMILAR MALFUNCTION CODES: TUBING DAMAGE - MINOR / LOCALIZED, TUBING IS SPLIT (ALONG THE LENGTH OF THE TUBING) OR HAS PINHOLES. THE COUNT OF COMPLAINTS IS 1. THE COMPLAINT NUMBER IS (B)(4). 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). FINAL CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: THE INVESTIGATION FOR THIS COMPLAINT WAS PREVIOUSLY COMPLETED ON 12/AUG/2025, UNDER CHILD COMPLAINT INVESTIGATION RECORD 2295211. THE INVESTIGATION HAS BEEN REVISED TO REFLECT THE ADD CONCLUSION. THE ORIGINAL INVESTIGATION REMAINS VALID AND HAS NOT BEEN MODIFIED. AS PART OF THIS REASSESSMENT, AN UPDATED EQMS SEARCH WAS PERFORMED WHICH IDENTIFIED ONE RELATED COMPLAINT FOR LOT 6010318. NO NCRS, CAPAS, TRENDS, OR SYSTEMIC ISSUES WERE FOUND. AS REQUIRED UNDER THE UPDATED REPORTABILITY CRITERIA, A FULL DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED. ALL IN PROCESS AND FINAL INSPECTIONS MET SPECIFICATION REQUIREMENTS, AND NO DEVIATIONS, REWORK ACTIVITIES, OR MAINTENANCE EVENTS ASSOCIATED WITH THE MALFUNCTION WERE IDENTIFIED. NO VISUAL EVIDENCE WAS AVAILABLE TO SUPPORT CONFIRMATION OF THE REPORTED ISSUE. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION ONLY. BASED ON THE EXPANDED INVESTIGATION INCLUDING UPDATED EQMS SEARCHES AND THE DHR REVIEW NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WI (MONTHLY TRIPS AND ALERTS). COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION, THE MALFUNCTION REMAINS UNCONFIRMED FOR THIS COMPLAINT.
E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: THE UNITED STATES.
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 PATIENT FACED INFUSION SET LEAKAGE EVENT ON (B)(6) 2025. THE LEAKAGE WAS IN THE TUBING THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 242122 | MINIMED SILHOUETTE | UNO COMFORT SHORT 60/13 SC1 MIN | FPA | UNOMEDICAL DEVICES S.A. DE C.V. | MMT-381A | 6010318 | 05705244019584 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |