ACCU-CHEK FLEXLINK
Report
- Report Number
- 3003442380-2024-32644
- Event Type
- Malfunction
- Date Received
- November 22, 2024
- Date of Event
- July 29, 2024
- Report Date
- June 11, 2025
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- PMA / PMN Number
- K143446
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
INITIAL AND FINAL MDR (B)(4) - DEVICE 2 OF 3. E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: BRAZIL.
SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2024-32644 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 6001069 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION GUIDELINE FOR TEST OF REFERENCE SAMPLES BUID-UMD VERSION 11 FOR THE CODE "LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED)." COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAS BEEN REQUESTED. THE FOLLOWING TEST WAS PERFORMED: VISUAL TEST ACCORDING TO WITH WORK INSTRUCTION VERSION 38 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1 ACCORDING TO WITH WORK INSTRUCTION VERSION 10 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 2 ACCORDING TO WITH WORK INSTRUCTION VERSION 7 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE LOT 6001069 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 43 ON THE PACKING PROCESS IN THE LINE MULTIVAC 07, ON 15/APR/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESS HAD BEEN FULFILLED AND MET THE REQUIREMENTS. DURING THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) IT WAS FOUND THAT DURING MANUFACTURING EXTENDED SAMPLING WAS PERFORMED DUE TO A PIECE LEAKING THROUGH THE UPPER MEMBRANE, THE SAMPLING WAS ACCEPTABLE BECAUSE NO OTHER DAMAGED PIECE CAME OUT. THE CASE WAS REVIEWED ON 25/NOV/2024 DURING THE INFUSION CARE DATA COMPLAINT REVIEW MEETING AND IT WAS DETERMINED TO BE AN ISOLATED CASE AND NO FURTHER ACTION IS REQUIRED. A QUERY WAS RUN IN TRACKWISE ]AGAINST MALFUNCTION CODE"LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED)." AND LOT 6001069 AND NO OTHER ONE COMPLAINT HAS BEEN REGISTERED IN TRACKWISE SINCE THE LAST 12 MONTHS. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: HARM NO REPORTABLE, NO DEFECT ON TESTS, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION, NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKETING SURVELLIENCE (PMS) PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE MARKET QUALITY REVIEW (OMQR) PROCEDURE.
SUPPLEMENTAL REPORT 01 - MDR (B)(4)- MDR 3003442380-2024-32644. 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 6001069 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDELINE FOR TEST OF REF. SAMPLES VERSION 11 FOR THE CODE LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED). COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAS BEEN REQUESTED. THE FOLLOWING TEST WAS PERFORMED: VISUAL TEST ACCORDING TO WITH WI VERSION 38 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1 ACCORDING TO WITH WI VERSION 10 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 2 ACCORDING TO WITH WI VERSION 7 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE LOT 6001069 WAS MANUFACTURED ACCORDING TO THE DOCUMENT WI VERSION 43 ON THE PACKING PROCESS IN THE LINE MULTIVAC 07, ON 15/APR/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESS HAD BEEN FULFILLED AND MET THE REQUIREMENTS. DURING THE REVIEW OF THE DHR IT WAS FOUND THAT DURING MANUFACTURING EXTENDED SAMPLING WAS PERFORMED DUE TO A PIECE LEAKING THROUGH THE UPPER MEMBRANE, THE SAMPLING WAS ACCEPTABLE BECAUSE NO OTHER DAMAGED PIECE CAME OUT. THE CASE WAS REVIEWED ON 25/NOV/2024 DURING THE IC DATA COMPLAINT REVIEW MEETING AND IT WAS DETERMINED TO BE AN ISOLATED CASE AND NO FURTHER ACTION IS REQUIRED. TRENDING: A QUERY WAS RUN IN DATABASE AGAINST MALFUNCTION CODE LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED) AND LOT 6001069 AND NO OTHER ONE COMPLAINT HAS BEEN REGISTERED IN DATABASE SINCE THE LAST 12 MONTHS. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: HARM NO REPORTABLE, NO DEFECT ON TESTS, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION, NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKETING SURVEILLANCE (PMS) PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE ON MARKET QUALITY REVIEW (OMQR) PROCEDURE.
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN BRAZIL. IT WAS REPORTED THAT PATIENT FACED THREE INFUSION SETS CANNULA LEAKAGE EVENTS ON (B)(6) 2024. NO FURTHER INFORMATION WAS AVAILABLE.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2598768 | ACCU-CHEK FLEXLINK | AC FLEXLINK I 8/60 10PCS. | FPA | UNOMEDICAL A/S | 04626435001 | 6001069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Male |