MINIMED QUICK-SET
Report
- Report Number
- 3003442380-2025-05036
- Event Type
- Malfunction
- Date Received
- April 2, 2025
- Date of Event
- February 25, 2025
- Report Date
- June 17, 2025
- Manufacturer
- UNOMEDICAL UM-D
- Product Code
- FPA
- UDI-DI
- 05705244017573
- PMA / PMN Number
- K160648
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES. INITIAL AND FINAL MDR (B)(4) -DEVICE 3 OF 3.
SUPPLEMENTAL REPORT 01 - MDR (B)(4) - MDR 3003442380-2025-05036. 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 REFERENCE SAMPLES FOR THE LOT 6010032 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE (B)(4) ON 11/JUN/2025. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK TEST. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: PACKING OF QUICK SET. THE LOT 6010032 WAS MANUFACTURED ACCORDING TO THE WI VERSION 82 AND PACKAGING IN THE MULTIVAC 12, ON 29/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY OF QUICK SET: THE LOT 4K05682 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ASSEMBLED IN THE QUICKSET LINE, ON 28/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05683 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ASSEMBLED IN THE QUICKSET LINE, ON 28/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K06592 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ASSEMBLED IN THE QUICKSET LINE, ON 30/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05698 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ASSEMBLED IN THE QUICKSET LINE, ON 02/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. GLUING OF QUICK SET THE LOT 4K05238 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 IN THE GLUING OF QUICK SET MACHINE MP04, MP08, ON 26/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05680 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 IN THE GLUING OF QUICK SET MACHINE MP04, MP05, MP08, ON 30/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05113 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 IN THE GLUING OF QUICK SET MACHINE MP04, MP08, ON 25/OCT/2024, 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 WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 16/JUN/2025 AGAINST MALFUNCTION CODE LEAKAGE (CUSTOMER STATES INFUSION SET LEAKS) AND LOT 6010032 AND FOUND OTHER ONE COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO HARM, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO OTHER COMPLAINT RECEIVED ON 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 THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED THREE INFUSION SET WAS LEAKING ON (B)(6) 2025. NO FURTHER INFORMATION WAS AVAILABLE.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 277649 | MINIMED QUICK-SET | UNO QUICK-SET 60/9 SC1 MECA | FPA | UNOMEDICAL UM-D | MMT-397A | 6010032 | 05705244017573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |