ACCU-CHEK FLEXLINK
Report
- Report Number
- 3003442380-2025-03584
- Event Type
- Malfunction
- Date Received
- March 13, 2025
- Date of Event
- November 20, 2024
- Report Date
- June 11, 2025
- Manufacturer
- UNOMEDICAL UM-D
- Product Code
- FPA
- PMA / PMN Number
- K143446
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INITIAL AND FINAL MDR (B)(4)- DEVICE 3 OF 4.
SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2025-03584. 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 PR (B)(4) HAS BEEN EVALUATED. THE BATCH 6001717 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 FOR THE CODE SOFT CANNULA DISLODGED FROM TISSUE DURING USE. COMPLAINT INVESTIGATIONS. 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. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001717 WAS MANUFACTURED ACCORDING TO THE WI VERSION 44 AND PACKAGING IN THE MULTIVAC M07, ON 29/JUL/2023, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLING OF FLEX SET CANNULA: THE LOT 3F00254 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 ASSEMBLED IN THE LINE L-02, ON 25/JUL/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 WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 03/APR/2025 AGAINST MALFUNCTION CODE SOFT CANNULA DISLODGED FROM TISSUE DURING USE AND LOT 6001717 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6001717 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON THE VISUAL INSPECTION FOR REFERENCE SAMPLES, NO HARM REPORTED, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION AND REPORTED MALFUNCTION. 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.
SUPPLEMENTAL REPORT 03 - (B)(4) MDR 3003442380-2025-03584. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED PMA/510(K) NUMBER UNDER G4. 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 6001717 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 FOR THE CODE SOFT CANNULA DISLODGED FROM TISSUE DURING USE. COMPLAINT INVESTIGATIONS. 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. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001717 WAS MANUFACTURED ACCORDING TO THE WI VERSION 44 AND PACKAGING IN THE MULTIVAC M07, ON 29/JUL/2023, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLING OF FLEX SET CANNULA: THE LOT 3F00254 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 ASSEMBLED IN THE LINE L-02, ON 25/JUL/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 WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 03/APR/2025 AGAINST MALFUNCTION CODE SOFT CANNULA DISLODGED FROM TISSUE DURING USE AND LOT 6001717 AND NO OTHER 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 THE VISUAL INSPECTION FOR REFERENCE SAMPLES, NO HARM REPORTED, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION AND REPORTED MALFUNCTION. 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.
SUPPLEMENTAL REPORT 02 - MDR (B)(4). CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED BRAND NAME UNDER D1, COMMON DEVICE NAME UNDER D2, MODEL NUMBER, SERIAL NUMBER AND PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER UNDER D4. 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.
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN BRAZIL. IT WAS REPORTED THAT THE PATIENT EXPERIENCED FOUR EVENTS WHERE THE CANNULA'S DETACHED FROM PATIENT'S SKIN. THE ISSUE OCCURED WITH FOUR INFUSION SETS ON (B)(6) 2024, (B)(6) 2024, (B)(6) 2024 AND (B)(6) 2024.THE SITE OF INSERTION WAS FLNAKS AND THIGHS. NO FURTHER INFORMATION AVAILABLE.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 991198 | ACCU-CHEK FLEXLINK | UNO INSET I 12/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL UM-D | 06593941001 | 6001717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR | Unknown |