MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS BRAHMS PROCALCITONIN 60T; VIDAS® BRAHMS PROCALCITONIN 60T

Model Number 30450-01

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A customer from the united states notified biomérieux of discrepant results when testing samples with vidas® brahms procalcitonin 60t (ref.30450-01, batch number: 1008325580).The customer performed correlation studies using plasma samples from an assortment of er patients obtained from another facility (26 samples were tested but the customer did not specify the number of patients represented in this sampling).The customer and the other facility both used vidas 3 instruments to perform the testing.The aim of these studies was not specified.The customer stated that they obtained lower values than the original test values obtained at the other facility and that the original values matched the clinical pictures of the patients.Of the 26 samples the customer retested, two samples resulted in a false negative result as compared to the original testing laboratory.Sample 6: 0.34 / 0.78 - false negative, sample 12: 0.39 / 0.59 - false negative.To be noted, the first facility analyzed the samples between (b)(6) 2021, while the second facility (the reporting customer) was not able to analyze all the samples before (b)(6)2021.Some samples may have been frozen and tested after more than 48 hours between the two facilities.The customer did not provide details regarding which of the 26 samples may have been tested more than 48 hours later.There is no indication from the customer that the comparative study results were used to treat patients.Biomerieux will initiate an internal investigation.

Manufacturer Narrative

This report was initially submitting following a customer from the united states notifying biomérieux of discrepant results when testing samples with vidas® brahms procalcitonin 60t (ref.30450-01, batch number: 1008325580).An internal biomérieux investigation was performed.The customer¿s samples were not available to be submitted for the investigation.Impact: method comparison.No patient issue.Investigation: 1.Device history record.The review did not highlight any issue during manufacturing for vidas brahms procalcitonin ref 30450-01 batch 1008325580.3.Quality control records: the analysis of control chart conducted on seven (7) internal samples (target: 0.08 ng/ml ; 1.22 ng/ml; 3.92 ng/ml ; 10.7 ng/ml ; 91.1 ng/ml ; 32.2 ng/ml and 147 ng/ml) for seven (7) batches of vidas brahms procalcitonin , including the customer batch: 1008325580, showed that all results are within specifications.The customer¿s lot is in the trend of the other batches.4.Tests/analysis performed: tests carried out on retained kit vidas brahms procalcitonin ref.30450-01, lot: 1008325580 and other reference batch: 1008233350.Unit: ng/ml.The first study was performed on 10 blood donor samples from efs (etablissement (b)(6).Each sample was tested on the both batches.All results are <0.05 ng/ml.The second study is the comparison of three (3) internal samples (target 0.08 ng/ml ; 1.22 ng/ml and 91.1 ng/ml ).The results obtained on the three (3) internal samples show that there is no drift of the lot: 1008325580 since its release, with the results obtained on the pv kit being similar to those obtained during the activity control.Moreover, the results for these three (3) samples are similar between the two (2) batches analyzed.5.Root cause analysis and conclusion: the investigation did not manage to identify any obvious root cause.The results obtained during the investigation were compliant with the specification of the parameter.According to the information given by the local customer service, some of the pre-analytical steps were not respected by customer.Samples separated from the clot can be stored at 2-8°c in stoppered tubes for up to 48 hours; if longer storage is required, freeze the sera or plasma at -25 +/-6°c.A the customer reported, some of the samples were tested after more than 48 hours, which can lead to erroneous results.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.According to all data above, there is no reconsideration of the performance of vidas brahms procalcitonin ref.30450-01, batch: 1008325580 its expectations.

• Brand Name: VIDAS BRAHMS PROCALCITONIN 60T
• Type of Device: VIDAS® BRAHMS PROCALCITONIN 60T
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• MDR Report Key: 11606065
• MDR Text Key: 280527566
• Report Number: 8020790-2021-00073
• Device Sequence Number: 1
• Product Code: PRI
• UDI-Device Identifier: 03573026223601
• UDI-Public: 03573026223601
• Combination Product (y/n): N
• PMA/PMN Number: K162827
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2022
• Device Model Number: 30450-01
• Device Catalogue Number: 30450-01
• Device Lot Number: 1008325580
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 04/01/2021
• Supplement Dates Manufacturer Received: 04/16/2021
• Supplement Dates FDA Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1