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On 28-jun-2022, a customer from hungary notified biomérieux of obtaining potential false overestimated result when testing patient samples with vidas brahms procalcitonin 60t (ref.30450, batch number: 1009072010, expiry date: 09-may-2023).The first patient is a 13 and half years old, tetraparetic and paraplegic, immunoglobulin-deficient, anemic boy who had repeated wound infections due to an illness of unknown origin 2 years ago.Based on bacteria cultured from wound secretions, he was treated with antibiotics (also in the surgery and internal medicine departments).For the patient n°1, the customer obtained the following results: (b)(6).According to the customer, at the time of the first test, the patient was in poor condition but then continuously improved, which was not reflected in the pct results.The second patient is a 15 year old boy with 60% burns (severe electric burn), who also had multiple bacterial sepsis.But at the time of the strange pct results, candida albicans from several of his blood culture bred, he also received targeted antibacterial/antifungal treatment for his infections or burn care was also carried out.For the patient n°2, the customer obtained the following results: (b)(6).According to the customer, a clinician notified the laboratory that pct results did not correlate with the status of the patient n°2.Based on the available information at the time of this assessment, there is no indication or report from the laboratory that the issue led to any adverse event related to patient's state of health.A biomérieux internal investigation will be initiated.Note: reference 30450 is not registered in the united states.The u.S.Similar device is product reference 30450-01.
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An internal investigation was performed following a notification from a customer from hungary who obtained a potential false overestimated result when testing patient samples with vidas brahms procalcitonin 60t (ref.30450, batch number: 1009072010, expiry date: 09-may-2023).The patient is a 15-year-old boy with 60% burns (severe electric burn), who also had multiple bacterial sepsis (maci and other infections), but at the time of the strange pct results, candida albicans from several of his hk bred, he also received targeted antibacterial/antifungal treatment for his infections or burn care was also carried out.On (b)(6) afternoon: 19,7 ng/ml on (b)(6) morning: 86 ng/ml on (b)(6) afternoon: 57 ng/ml on (b)(6): 33 ng/ml.1.Device history record: the review did not highlight any issue during manufacturing vidas brahms pct ref 30450 lot: 1009072010.2.Complaint analysis: the complaint analysis did not reveal this issue as a systemic quality issue.3.Test/analysis performed.3.1.Control charts analysis: the complaints laboratory analyzed the results of 5 internal samples targeted between 0.08 ng/ml and 118 ng/ml, on 9 different batches of vidas brahms pct ref 30450 including customer¿s lots: 1009072010.The analysis of the control charts showed that all results are within specifications.Customer¿s lots are in the trend of the other lots.3.2.Tests performed by complaint laboratory: on internal samples: the complaints laboratory tested 4 internal samples with concentrations distributed at different level of vidas brahms pct curve (targets 0.08, 0.30, 1.22 and 67.8 ng/ml) with the retain kits vidas brahms pct 1009072010, 1009216670 and another batch for comparison 1009462790.All samples results are within their expected specifications.There was no significant evolution over time of the batches mentioned by the customer since batches released.We noticed for vidas brahms pct batch: 1009216670, a non-reproducible result (1 result /3) out of specification due to a preanalytical issue.After another centrifugation, the results are reproducible and complied to vidas brahms specification.According to package insert information, in section ¿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.¿ 4.Analysis of litterature: cases of false positive reported in the literature (i.E.Falsely high levels in the absence of a bacterial infection): new borns, systemic fungal infection, severe mechanical trauma, following surgical trauma, severe burns, acute respiratory distress syndrome, heat strokes acute attacks of plasmodium falciparum malaria.Administration of monoclonal or polyclonal anti-thymocyte globulin in the treatment of acute rejection after transplantation chemical pneumonitis patients with medullary thyroid cancer, small cell cancer of the lung, carcinoid, tumors with paraneoplastic hormone production inflammation associated with ¿cytokine storms¿, e.G.Ilb¿ in familial mediterranean fever, therapeutic infusions of tnfa for melanoma depending on the clinical context (severe burn, surgery, cancer, other co-infection.), the type of treatment, we can observe a falsely increase of pct in many situations not due to the method but to the pct molecule itself.5.Root cause analysis and conclusion according to all information above, no anomaly was highlighted with the control chart analysis, the analysis of quality data and the tests performed on retain kits vidas brahms pct 1009072010 using internal samples.Customer¿s issue, ie overestimated results, were not reproduced by complaints laboratory during the investigation conducted on internal samples materials.Unfortunately, the investigation did not manage to identify any obvious root cause.Without customer¿s return sample and kit, we cannot pursue investigation.According to the package insret, in the chapter range of expected values ¿risk assessment for progression to severe sepsis and septic shock: in agreement with the literature (3, 4), the results obtained with vidas®b¿r¿a¿h¿m¿s pct¿ during a study performed on patients admitted to intensive care units (refer to the "clinical performance" section) are as follows: a concentration < 0.5 ng/ml represents a low risk of severe sepsis and/or septic shock.A concentration > 2 ng/ml represents a high risk of severe sepsis and/or septic shock.Nevertheless, concentrations < 0.5 ng/ml do not exclude an infection, on account of localized infections (without systemic signs) which can be associated with such low concentrations, or a systemic infection in its initial stages (< 6 hours).Furthermore, increased procalcitonin can occur without infection.¿ based on the investigation outcomes, there is no reconsideration of the performance of vidas brahms pct ref 30450 1009072010.
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