MAUDE Adverse Event Report: BIOMÉRIEUX SA VIDAS® B·R·A·H·M·S PCT ¿

Model Number 30450-01

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Event Description

A customer in the united states notified biomérieux of observing non reproducible overestimated results when testing qc samples using vidas brahms procalcitonin 60t (ref.30450-01, batch 1009137690, expiry date 07-jun-2023).Results on (b)(6) 2022 for samples ln41: level 1: 0.34 then 0.34.Level 2: 11.93 then 11.97.Level 3: 35.22 then 34.05.Level 4: 62.79 then 55.70.Level 5: 139.60 then 124.78.Level 6: the first results were > 200 ng/ml on both runs.The upper end of the measurement range is 200ng/ml.Therefore, the customer performed 1:10 dilution and then divided by 2.The final results are 253.19 and 251.52 obtained on (b)(6) 2022.The allowable error rate is 12.5% and it is exceeded for samples level 2, level 4, 5 and 6 compared to the peer mean.The customer mentioned that there was no delay in reporting.As the samples are qc samples, there is no patient impact.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal investigation was performed following notification from a customer in the united states of observing non reproducible overestimated results when testing qc samples using vidas brahms procalcitonin 60t (ref.30450-01, batch 1009137690, expiry date 07-jun-2023).Investigation results: 1.Complaint analysis and device history record review the review did not highlight any issue during manufacturing for vidas brahms procalcitonin ref 30450-01, lot 1009137690.There is no capa or non-conformity on vidas brahms procalcitonin reference 30450 linked to the customer's issue.The analysis of complaints did not reveal a systemic quality issue.The analysis of control chart carried out on 4 internal samples (target 10.9 , 32.2 , 91.1 , 159 ng/ml) on 7 batches of vidas brahms procalcitonin ref 30450/ 30450-01 including the customer batch 1009137690 showed that all results are within specifications.The customer¿s lot is in the trend of the other batches.Tests performed internally: analyses were done on retain kit vidas brahms procalcitonin ref 30450-01, lot 1009137690 and 3 internal samples.Sample 1 = 187.57 ng/ml result during control of batch = 173.19 and 171.79 ng/ml sample 2 = 29.28 ng/ ml result during control of batch = 30.80 and 30.04 ng/ml sample 3 = 11.71 ng/ml result during control of batch = 10.43 and 10.95 ng/ml.All results conform to expected values.There is no drift of the batch since its release.Linearity study: in order to check the linearity of vidas brahms procalcitonin ref 30450-01, lot 1009137690, a linearity study using internal sample with high concentration diluted in negative sample from etablissement français du sang (efs) was carried out : the following samples concentrations were obtained: low, medium low, medium, medium high and high.Protocol followed: all the samples were tested in duplicate on vidas brahms procalcitonin ref 30450-01, lot 1009137690.Results obtained: the linearity results observed on these samples were acceptable without any significant problem of concentration or recovery on the diluted samples.Conclusion: the results of the investigation show that the kit vidas brahms procalcitonin ref 30450-01, lot 1009137690 is still within the expected performance.In the past, investigations have shown that a higher variability was observed on quality control materials than on natural patient samples.Excellent linearity results were observed on natural samples.This behavior, named matrix effect is largely described in articles and some guidelines.This is due to the fact that quality control samples are not totally native samples but they are processed by spiking in this specific case recombinant antigen.It is mentioned in the clsi guideline ep14-a3 that processed samples used as qc material (e.G eqa) can have matrix effect.¿current scientific data suggest that such use of pt eqa results is not always feasible because of matrix effects.These processed materials us as pt eqa samples sometimes do not behave like patient samples routinely analyzed in the laboratory.Biases not generally seen with fresh biological fluids, are frequently seen with pt eqa samples¿.The result is linked to pre-analytic steps and lot used.The pre-analytic steps : reconstitution of the lyophilized vials (diluent, volume, waiting time, mixing).The analytic steps : after reconstitution (mixing before the run).The important point also is to homogenize the sample before test.

• Brand Name: VIDAS® B·R·A·H·M·S PCT ¿
• Type of Device: VIDAS® B·R·A·H·M·S PCT ¿
• Manufacturer (Section D): BIOMÉRIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMÉRIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer Contact: matt floretta ; 595 anglum rd; hazelwood, MO 63042
• MDR Report Key: 15342601
• MDR Text Key: 300677650
• Report Number: 8020790-2022-00092
• Device Sequence Number: 1
• Product Code: PRI
• UDI-Device Identifier: 03573026223601
• UDI-Public: 03573026223601
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162827
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

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: 06/07/2023
• Device Model Number: 30450-01
• Device Catalogue Number: 30450-01
• Device Lot Number: 1009137690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 10/26/2022
• Supplement Dates FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1