MINIMED QUICK-SET
Report
- Report Number
- 3003442380-2025-11379
- Event Type
- Malfunction
- Date Received
- July 8, 2025
- Date of Event
- June 25, 2025
- Report Date
- July 23, 2025
- Manufacturer
- UNOMEDICAL DEVICES S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 05705244017450
- PMA / PMN Number
- K160648
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
(B)(6) 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: THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6010990 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 TUBNG CONNECTOR DETACHED FROM INFUSION SET (CANNULA PART/BASE PIECE). COMPLAINT INVESTIGATION: 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: STATIC PULL TUBING-TUBING CONNECTOR ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010990 WAS MANUFACTURED ACCORDING TO THE WI VERSION 82 AND PACKAGING IN THE MACHINE 12, ON 18/JAN/2025, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY: THE LOT 5A03807 WAS ASSEMBLED ACCORDING TO THE WI VERSION 27 ON-LINE INSPECTION ON 17-JAN-2025, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 5A01031 WAS ASSEMBLED ACCORDING TO THE WI VERSION 27 ON-LINE INSPECTION ON 18-JAN-2025, WITH A TOTAL OF (B)(4) UNITS EACH. THE LOT 5A01032 WAS ASSEMBLED ACCORDING TO THE WI VERSION 27 ON-LINE INSPECTION ON 18-JAN-2025, WITH A TOTAL OF (B)(4) UNITS EACH. GLUING CONNECTOR: THE LOT 5A00996 WAS GLUED ACCORDING TO THE WI 4905078 VERSION 42, LINE 04 AND 08 ON 16-JAN-2025, 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 22/JUL/2025 AGAINST MALFUNCTION CODE TUBNG CONNECTOR DETACHED FROM INFUSION SET (CANNULA PART/BASE PIECE) AND LOT 6010990 AND NO MORE COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CAPA PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6), UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET TUBING DETACHED EVENT ON (B)(6) 2025 AT SITE LOCATION. THE INSERTION SITE WAS THE ARM. INFUSION SET WAS USED FOR ONE DAY. 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 |
|---|---|---|---|---|---|---|---|
| 1843952 | MINIMED QUICK-SET | UNO QUICK-SET 60/6 SC1 MECA | FPA | UNOMEDICAL DEVICES S.A. DE C.V. | MMT-399A | 6010990 | 05705244017450 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |