QUICK SET
Report
- Report Number
- 3003442380-2025-16204
- Event Type
- Injury
- Date Received
- November 11, 2025
- Date of Event
- October 20, 2025
- Report Date
- November 7, 2025
- Manufacturer
- UNOMEDICAL DEVICES S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 05705244017573
- PMA / PMN Number
- K160648
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES. 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: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6002729, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 06-NOV-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL 6002729. THE COUNT OF COMPLAINT IS 3 WHICH IS EXCEEDS 3. FURTHER INVESTIGATION IS REQUIRED VIA CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION ASSESSMENT USING STATISTICAL ANALYSIS. THE COMPLAINTS NUMBER ARE: (B)(4) DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002729 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 77 AND MANUFACTURED IN THE MULTIVAC 12 ON 14-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY, LOT 3H00387 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND MANUFACTURED IN THE QUICKSET LINE, ON 14-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY, LOT 3H00388 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND MANUFACTURED IN THE QUICKSET LINE, ON 14-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY, LOT 3H00725 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND MANUFACTURED IN THE QUICKSET LINE, ON 14-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 3H00363 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE GLUING MACHINE MP08, ON 12-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 3H00361 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE GLUING MACHINE MP08, ON 13-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 3H00364 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE GLUING MACHINE 04, ON 13-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 3H00365 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE GLUING MACHINE 05, ON 11-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 3G03005 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE GLUING MACHINE 04, ON 14-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. TEST RESULTS: IN ORDER TO TEST THE PRODUCT, THE RETURNED SAMPLE(S) FROM THE LOT HAVE BEEN REQUESTED. NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED. THE REFERENCE SAMPLES WERE ALREADY TESTED IN THE COMPLAINT (B)(4). CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, THE THRESHOLDS OF 3 REPORTABLE COMPLAINTS ARE MET FOR THE LOT IN QUESTION AND MALFUNCTION CODE; FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT REQUIRES FURTHER CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION ASSESSMENT
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: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6002729, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 06-NOV-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL 6002729. THE COUNT OF COMPLAINT IS 3 WHICH IS EXCEEDS 3. FURTHER INVESTIGATION IS REQUIRED VIA CAPA DETERMINATION ASSESSMENT USING STATISTICAL ANALYSIS. THE COMPLAINTS NUMBER ARE: (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002729 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 77 AND MANUFACTURED IN THE MULTIVAC 12 ON 14-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY, LOT 3H00387 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND MANUFACTURED IN THE QUICKSET LINE, ON 14-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY, LOT 3H00388 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND MANUFACTURED IN THE QUICKSET LINE, ON 14-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY, LOT 3H00725 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND MANUFACTURED IN THE QUICKSET LINE, ON 14-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 3H00363 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE GLUING MACHINE MP08, ON 12-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 3H00361 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE GLUING MACHINE MP08, ON 13-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 3H00364 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE GLUING MACHINE 04, ON 13-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 3H00365 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE GLUING MACHINE 05, ON 11-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 3G03005 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE GLUING MACHINE 04, ON 14-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. TEST RESULTS: IN ORDER TO TEST THE PRODUCT, THE RETURNED SAMPLE(S) FROM THE LOT HAVE BEEN REQUESTED. NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED. THE REFERENCE SAMPLES WERE ALREADY TESTED IN THE COMPLAINT (B)(4). ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT (B)(4). CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, THE THRESHOLDS OF 3 REPORTABLE COMPLAINTS ARE MET FOR THE LOT IN QUESTION AND MALFUNCTION CODE; FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT REQUIRES FURTHER CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION ASSESSMENT.
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED LOW BLOOD GLUCOSE EVENT ON (B)(6) 2025. THE PATIENT WAS TREATED BY DISPATCHING EMERGENCY MEDICAL SERVICES (EMS). THE PATIENT WAS TREATED AT HOME AND WAS NOT TAKEN TO A HOSPITAL. THE PATIENT TREATED BY CONNECTING TO INTRAVENOUS WITH GLUCOSE. THE PATIENT ALSO EXPERIENCED UNCONSCIOUSNESS, NOT BREATHING WELL AND HIGH BLOOD PRESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 1933979 | QUICK SET | UNO QUICK-SET 60/9 SC1 MECA | FPA | UNOMEDICAL DEVICES S.A. DE C.V. | MMT-397A | 6002729 | 05705244017573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |