| Catalog Number 30450 |
| Device Problem
Low Test Results (2458)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 01/28/2022 |
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Event Type
malfunction
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Event Description
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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.Pct result indicates: < 0.5 ng/ml: low risk of severe sepsis and/or septic shock > 2 ng/ml: high risk of severe sepsis and/or septic shock description of the issue: on (b)(6) 2022, a customer in (b)(6) notified biomérieux of out of range low results when testing with vidas® brahms rocalcitonin 60t (ref.30450, lot #1009009480, expiry date: 29-mar-2023) in context of external quality control (qc).On (b)(6) 2022, the client did perform quality control tests with the external quality control mas omniimmune (thermo) in conjunction with the newly opened kit lot #1009009480.The client obtained the following results: qc1 (low level): 0.187 ¿ acceptable range: 0.23-0.35 qc2 (mid level): 1.787 ¿ acceptable range: 1.95-2.93 qc3 (high level): 14.523 - acceptable range: 16.8-25.2 as it was a quality control test, no patient sample was involved.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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Manufacturer Narrative
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An internal investigation was performed following notification from a customer from hong kong of obtaining out of range low results when testing with vidas® brahms procalcitonin 60t (ref.30450, lot #1009009480, expiry date: 29-mar-2023) in context of external quality control (qc).1.Device history record the analysis of the batch history record of vidas pct ref.30450 lot 1008722440 did not highlight any issue.2.Complaint analysis the complaint analysis did not reveal this issue as a systemic quality issue.3.Test/analysis performed customer¿s sample results expected ranges on package insert were as follow: oim21111a - 0.23 - 0.35 ng/ml, oim21112a - 1.95 - 2.93 ng/ml, oim21113a - 16.8 - 25.2 ng/ml, customer values on 2 lots 1009009480 vs 1008886330: qc1: 0.187 vs 0.235, qc2: 1.787 vs 2.21, qc3: 14.523 vs 18.86, it is to be noted that the customer used these controls frozen after opening vial.The thermo fisher mas package insert is not clear on the shelf life of the vial after opening.However, on the thermo scientific mas website, the following information is mentioned: 36 months shelf life from date of manufacture @ -25 to 15°c.30 days opened @ 2 to 8°c.In conclusion, this control cannot be refrozen.Customer¿s material no customer¿s material was returned for investigation control charts analysis the complaint laboratory observed 4 internal samples, on 8 different batches of vidas brahms procalcitonin (pct) ref.30450 including customer¿s lots 1009009480 and 1008886330: pa122 ranges 0.30 (0.20 ¿ 0.40) activity lot 1009009480: 0.29 ng/ml / lot 1008886330: 0.27 ng/ml.Pa123 ranges 0.34 (0.23 ¿ 0.45) activity lot 1009009480: 0.32 ng/ml / lot 1008886330: 0.34 ng/ml.Pa133 ranges 20.3 (15.9 ¿ 24.8) activity lot 1009009480: 17.77 ng/ml / lot 1008886330: 19.72 ng/ml.Pa137 ranges 32.2 (25.1 ¿ 39.4) activity lot 1009009480: 31.89 ng/ml / lot 1008886330: 32.95 ng/ml.The analysis of the control charts showed that all results are within the specifications.Customer¿s lot is in the trend of the other lots.Tests performed by complaint laboratory without return customer¿s samples, the complaint laboratory tested 2 other external samples probioqual 22bg01 et 22bg02 (exp 31 jan 2023) with expected ranges for 22bg01 5.108 (4.342-5.874) and for 22bg02 55.279 (46.987-63.571) on retain kits of vidas brahms procalcitonin (pct)ref.30450 customer¿s lot 1009009480 and another vidas brahms procalcitonin (pct) ref.30450 lot 1009233470.All results are within their expected specifications and similar between the two batches.There was no drift of the customer¿s lot since its release.4.Root cause analysis and conclusion the investigation did not reproduce the customer's issue, when testing external samples probioqual 22bg01 et 22bg02 on vidas brahms procalcitonin (pct) ref.30450 customer¿s lot 1009009480 and another lot of vidas brahms procalcitonin (pct) ref.30450 all the results are on expected ranges without any difference of results between 2 lots.Customer used these controls frozen after opening vial whereas this control cannot be refrozen.The root cause is probably a stability issue for this external control according to the data mentioned above, there is no reconsideration of vidas brahms procalcitonin (pct) ref.30450 lot 1009009480.
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Search Alerts/Recalls
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