Intended use: vidas® b·r·a·h·m·s pct¿ (pct) is an automated test for use on the instruments of the vidas® family for the determination of human procalcitonin in human serum or plasma (lithium heparinate) using the elfa (enzyme-linked fluorescent assay) technique.Used in conjunction with other laboratory findings and clinical assessments, vidas® b·r·a·h·m·s pct¿ is intended for use as follows: to aid in the risk assessment of critically ill patients on their first day of icu admission for progression to severe sepsis and septic shock, to aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the icu or when obtained in the emergency department or other medical wards prior to icu admission, using a change in pct level over time, to aid in decision making on antibiotic therapy for patients with suspected or confirmed lower respiratory tract infections (lrti) ¿ defined as community-acquired pneumonia (cap), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (aecopd) ¿ in an inpatient setting or an emergency department, to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis.Description of the issue: on (b)(6) 2021, a customer in united-states notified biomérieux of out of range high results when testing with vidas® brahms procalcitonin 60t (ref.30450-01, lot #1008647850, expiry date: 14-sep-2022) in context of cap survey using external quality control.To be noted that the client observed the same issue with another lot (lot #1008448080).This case has been reported separately (cn-(b)(4)).For the survey completed on (b)(6) 2021 on pct lot #1008647850, which was calibrated (b)(6) 2021, the client obtained the following results: s1 rfv 2443 (range 1909 - 3410; mean 2659.5), s2 rfv 455 (range 321 - 573; mean 447), c1 18.68 ng/ml (range 14.33 - 22.39ng/ml), c2 1.82 ng/ml (range 1.37 - 2.21 ng/ml).Their cap survey results were as follows: pct-04 6.68 ng/ml (cap acceptable range 5.89 - 7.98 ng/ml), pct-05 12.91 ng/ml (cap acceptable range 0.27 - 0.56 ng/ml) out of range high, pct-06 2.06 ng/ml (cap acceptable range 1.69 - 2.54 ng/ml).As it was a quality control sample, no patient sample was involved.There is no indication or report from the laboratory that the issue led to any adverse event related to any patient's state of health nor delayed result.A biomérieux internal investigation will be initiated.
|
An internal investigation was performed following notification from a customer in united-states of out of range high results when testing with vidas® brahms procalcitonin 60t (ref.30450-01, lot #1008647850, expiry date: 14-sep-2022) in context of cap survey using external quality control (cap survey sample pct-05).**investigation** 1.Device history record: the review did not highlight any issue during manufacturing for vidas® pct ref.30450-01 lot 1008647850.2.Complaint analysis: the complaint analysis did not reveal this issue as a systemic quality issue.3.Analysis performed: product return.There is no remaining volume for the sample pct-05.Investigation protocol and and obtained results.Control charts analysis.The analysis of the control charts performed on four (4) internal samples (target at 0.30, 0.34, 0.87 and 1.22 ng/ml) and seven (7) lots including customer's lot 1008647850 showed that all results are within specifications.Customer¿s lot is in the trend compared to the other lots.2.Investigation: **tests performed** ** internal samples** three (3) samples targeted at 0.27, 0.28 and 0.76 ng/ml were tested with vidas® pct lot 1008647850 (customer¿s lot).=>all samples tested are compliant with their specification and the results are similar to those obtained before the batch release.** cap survey external quality control** the complaints laboratory subscribes to cap survey eqa scheme and tests those quality control samples such as an ordinary user.The sample pct-05 was tested at the time of cap survey assessment with vidas® pct batch 1008687840 and we obtained the following result: pct-05 = 0.43 ng/ml cap survey specification range [0.27-0.56] ng/ml for this investigation, pct-05 sample was tested with vidas® pct lot 1008647850.Pct-05 = 0.42 ng/ml the customer¿s results were not reproduced internally when testing pct-05 sample with vidas® pct lot 1008647850 (customer¿s lot) and another lot 1008687840.The results obtained on both batches were not significantly different.3.Root cause analysis: 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 kit vidas® pct lot 1008647850 using internal samples and cap survey external quality control materials.We did not reproduced the customer¿s issue with the same cap survey material, i.E.Pct-05 sample.Therefore the mainly hypothesis is a preanalytical issue at customer's level.According to the above data, kit vidas® pct ref 30450-01 lot 1008647850 is within the expected performances.
|