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On (b)(6) 2022, a customer in israel notified biomérieux of observing non reproducible results when testing a patient sample using vidas® brahms procalcitonin 60t (ref.30450, lot 1009154290, expiry date 11-jun-2023).An intensive care unit patient was tested with vidas pct.On (b)(6) 2022 a collection was made and sent to the laboratory and the pct test gave a negative result, 1.84 ng/ml.The physician asked for another collection on the same day, and the results was negative again, 1.17 ng/ml.The two runs were made by two different laboratory technicians.On (b)(6) 2022, the laboratory technician checked the serum tubes and found that a fibrin like phlegm appeared in the tube.The laboratory repeated the two runs with a different lot# after removing the phlegm and the results fitted to the trend observed by physician: 1st sample: 7.63 ng/ml and second sample: 12.63 ng/ml.The tubes were vacuette (b)(4).The sample type was serum.The coagulation time: centrifugation is done after at least 15 minutes after blood collection.Centrifuge setting : 2200 rcf, 10 minutes at 20°c.After centrifugation, the tubes were kept at room temperature upon testing.The customer was requested to store aliquots in -20°c.No separation normally done for testing tubes.Anti-coagulant treatment: the patient is getting prolonged iv heparin.The wrong results were transmitted to the physician.However, no wrong treatment was given to the patient following the issue.No delay was observed by the customer.A biomérieux internal investigation will be initiated.Note: (b)(4) is not registered in the united states.The u.S.Similar device is product (b)(4).
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An internal investigation was performed following notification from a customer in isreal of observing non reproducible results when testing a patient sample using vidas® brahms procalcitonin 60t (ref.30450, lot 1009154290, expiry date 11-jun-2023).Investigation 1.Device history record the review did not highlight any issue during manufacturing for vidas brahms procalcitonin reference 30450, lot 1009154290.There is no capa or non-conformity on vidas brahms procalcitonin reference 30450 linked to the customer's issue.2.Complaint analysis the analysis of complaints did not reveal a systemic quality issue.3.Test/analysis performed customer¿s material customer samples were not available for investigation.Further investigation was completed using internal samples.Customer¿s results 12aug2022, on vidas pct lot 1009154290: - sample 42106003 result 1.84 ng/ml - sample 42090802 result 1.17 ng/ml 16aug2022, the lab technician checked the serum tubes and found that a fibrin like phlegm appears in the tube.The lab repeated the two runs on vidas ptc different lot 1009216670, after removing the phlegm and the results fit the trend observed by the physician.- sample 42106003 result 7.63 ng/ml - sample 42090802 result 12.63 ng/ml.Control charts analysis the complaints laboratory analyzed four (4) internal samples (targets 3.92 ¿ 1.22 ¿ 7.80 and 10.9 ng/ml), on six (6) batches including the lot 1009154290 mentioned by the customer.=> the analysis of the control charts showed that all results are within specifications.Customer¿s lot is in the trend of the other lots.Tests performed by complaint laboratory the complaints laboratory tested three (3) internal samples (targets 1.39 ¿ 11.37 and 7.28 ng/ml) with the retain kits vidas brahms pct lots 1009154290 and 1009216670 used by costumer.=> all sample results are within their expected specifications.There was no drift of the customer lot since its release.Customer information** the lab technician checked the serum tubes and found that a fibrin like phlegm appears in the tube.Package insert information** chapter sample preparation ¿the pre-analytical step, including the preparation of blood samples, is an essential first step when performing medical analyses.In accordance with good laboratory practice, this step is performed under the responsibility of the laboratory manager.Insufficient clot time can result in the formation of fibrin with micro-clots that are invisible to the naked eye.The presence of fibrin, red blood cells, or suspended particles can lead to erroneous results.Samples containing suspended fibrin particles or erythrocyte stroma should be centrifuged before testing.For serum specimens, ensure that complete clot formation has taken place prior to centrifugation.Some specimens, especially those from patients receiving anticoagulant or thrombolytic therapy, may exhibit increased clotting times.¿ 4.Root cause analysis and conclusion according to all information above, no anomaly was highlighted with the control chart analysis, or the analysis of quality data and the tests performed on retain kits vidas brahms pct 1009154290 and 1009216670 using internal samples.The customer¿s issue of non-reproducible results between two (2) lots, was not reproduced by complaints laboratory during the investigation conducted on internal samples.Without the concerned customer's sample, it was not possible to pursue further investigation.Hypothesis/likely root cause: it is a pre-analytic issue as when the technician checked the sample tubes, there was the presence of fibrin.According to package insert for the pre-analytical step, including the preparation of blood samples, this is an essential first step when performing medical analyses.There is no reconsideration of the performance of vidas brahms pct reference 30450 lot 1009154290.
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