VIDAS BRAHMS PROCALCITONIN 60T
Report
- Report Number
- 8020790-2021-00160
- Event Type
- Malfunction
- Date Received
- July 12, 2021
- Report Date
- September 1, 2021
- Manufacturer
- BIOMERIEUX SA
- Product Code
- PRI
- UDI-DI
- 03573026223601
- PMA / PMN Number
- K162827
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
A CUSTOMER IN THE U.S.A NOTIFIED BIOMÉRIEUX THAT THEY OBTAINED THAT WERE ¿OUT OF RANGE¿ (TOO LOW) IN ASSOCIATION WITH API CONTROL (SAMPLE 2 PCA-02) WITH VIDAS PCT REF 30450-01 LOT 1008544030. PER INFORMATION FROM THE CUSTOMER, THEY WERE NOT FOLLOWING THE RECOMMENDATIONS OF THE SUPPLIER, WHICH DIRECTS USERS TO TEST THE SAMPLES IMMEDIATELY AFTER RECONSTITUTION; ON THIS LOT (LOT 1008544030) THE CUSTOMER TESTS THE SAMPLES ONE MONTH AFTER RECONSTITUTION. THE CUSTOMER ALSO CONFIRMED THAT THEY DID NOT HAVE MORE OF THE SAMPLE IN QUESTION TO SUBMIT FOR TESTING. INVESTIGATIONAL TESTS WERE PERFORMED ON INTERNAL SAMPLES. INVESTIGATION: THE ANALYSIS OF THE BATCH HISTORY RECORDS FOR THE VIDAS PCT LOT 1008544030 SHOWED NO ANOMALIES DURING THE MANUFACTURING, CONTROL OR PACKAGING PROCESSES. CONTROL CHART REVIEW CONTROL CHART ANALYSIS WAS CARRIED OUT ON 4 INTERNAL SERA (2 WITH TARGETS NEAR TO API SAMPLE 2 : 0.87 NG/ML AND 1.22 NG/ML AND 2 WITH TARGETS : 3.03 NG/ML AND 3.92 NG/ML), AND 10 BATCHES INCLUDING THE LOT MENTIONED BY THE CUSTOMER ¿ 1008544030. ALL VALUES ARE WITHIN SPECIFICATIONS, AND THE CUSTOMER¿S LOT IS CONSISTENT WITH THE OTHER LOTS. THE COMPLAINTS LABORATORY TESTED FOUR INTERNAL SAMPLES (SAME SAMPLES THAN ABOVE) ON RETAIN KITS OF VIDAS PCT LOTS 1008507900 AND 1008544030. ALL SAMPLE RESULTS ARE WITHIN THEIR EXPECTED SPECIFICATIONS AND SIMILAR TO THOSE OBSERVED BEFORE THE BATCHES RELEASE. THE RESULTS DO NOT SHOW ANY EVOLUTION OVER TIME ON THE TWO LOTS OF VIDAS PCT. THE COMPLAINTS LABORATORY SUBSCRIBES TO DIFFERENT EQA SCHEME, AND TESTS SEVERAL QUALITY CONTROL SAMPLES. THEY TESTED FIVE SAMPLES OF AUDIT MICRO CONTROLS LINEARITY (TARGETS BETWEEN 0.155 NG/ML TO 222, 816 NG/ML) ON FOUR VIDAS PCT LOTS, INCLUDING THE CUSTOMER¿S LOT. ALL RESULTS OBTAINED ARE COMPLIANT TO THE EXPECTED RESULTS. ROOT CAUSE: ACCORDING TO ALL INFORMATION ABOVE, NO ANOMALY WAS HIGHLIGHTED WITH THE CONTROL CHART ANALYSIS, THE ANALYSIS OF QUALITY DATA AND THE TESTS PERFORMED ON THE RETAIN KITS OF VIDAS PCT LOT 1008507900 AND 1008544030. THERE WAS NO ANOMALY OBSERVED ON THE INTERNAL SAMPLES AND ON SAMPLES TESTED FROM AUDIT MICRO CONTROLS LINEARITY. WITHOUT CUSTOMER¿S RETURN SAMPLE, FURTHER INVESTIGATION CANNOT BE PURSUED. THE MAIN HYPOTHESIS COULD BE AN ISSUE OCCURRED DURING THE RECONSTITUTION OR THE STORAGE OF THE VIAL. CONSEQUENTLY, THERE IS NO RECONSIDERATION OF THE PERFORMANCE OF VIDAS PCT REFERENCE (B)(4) LOT 1008544030.
ON 14-JUN-2021, A CUSTOMER IN UNITED STATES NOTIFIED BIOMÉRIEUX OF OUT OF RANGE LOW WHEN TESTING API (AMERCIAN PROFICIENCY INSTITUTE) EEQ SAMPLE WITH VIDAS BRAHMS PROCALCITONIN 60T (REF: 30450-01), (LOT:1008544030, EXPIRY DATE: 25-JUL-2022) IN CONTEXT OF EXTERNAL QUALITY CONTROL (QC). BETWEEN (B)(6)-2021 AND (B)(6)-2021, THE CUSTOMER RETESTED THE PCA-02 SAMPLE THAT WAS INITIALLY TESTED ON (B)(6)-2021 AND WHICH WAS OUT OF RANGE: EXPECTED RANGE : 0.76 -1.51 NG/ML REPEAT RESULTS 0.56 NG/ML TESTED (B)(6) 2021, REPEAT RESULTS 0.56 NG/ML TESTED (B)(6) 2021, REPEAT RESULT 0.58 NG/ML TESTED (B)(6) 2021. THERE IS NO PATIENT ASSOCIATED WITH THIS EXTERNAL QC SAMPLE; THEREFORE, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THE CUSTOMER STATED THERE WAS NO DELAY IN REPORTING RESULTS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1052093 | VIDAS BRAHMS PROCALCITONIN 60T | VIDAS® BRAHMS PROCALCITONIN 60T | PRI | BIOMERIEUX SA | 30450-01 | 1008544030 | 03573026223601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |