MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® BRAHMS 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

Issue description.On (b)(6) 2022, a customer from united states notified biomérieux of obtaining an overestimated result when testing with vidas brahms procalcitonin 60t (ref.30450-01, batch number: 1009004570, expiry date: (28-mar-2023) on one external quality control, cap survey pct 01.The qc sample is a qc from external quality assessment cap survey, identified as pct 01.On (b)(6) 2022, the customer tested three different samples and obtained the following results: pct-01: customer's result=11.41 ng/ml for mean 8.640 ng/ml (366 labs) and range [6.98-10.30] too high.Pct-02: customer's result=2.69 ng/ml for mean 2.726 ng/ml (377 labs) and range [2.20-3.25].Ok pct-03: customer's result=0.61 ng/ml for mean 0.546 ng/ml (372 labs) and range [0.40-0.69].Ok on (b)(6) 2022, the customer tested again the qc sample id pct-01: customer's result=10.90 ng/ml for range [6.98-10.30].The result was still overestimated.Calibrations were done on (b)(6) 2022 and (b)(6) 2022; they were valid.There is no potential patient¿s impact due to this issue, as it is in a context of external quality control.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 any delayed result.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

An internal investigation was performed following notification from a customer in the united states that they obtained overestimated results observed when testing a quality control sample on vidas b.R.A.H.M.S pct batch 1009004570.An internal investigation was performed following notification from a customer in the united states that they obtained overestimated results observed when testing a quality control sample on vidas b.R.A.H.M.S pct batch 1009004570.Customer material no material was received from the customer.Complaint analysis the complaint analysis did not reveal this issue as a systemic quality issue *analysis and tests conducted by complaints laboratory* control chart analysis.Control chart analysis was carried out on four (4) internal samples (with respective targets at 33.03 / 3.92 / 7.80 and 10.7 ng/ml)on seven (7) batches of vidas b.R.A.H.M.S pct ref.30450 including lot 1009004570 mentioned by the customer.The analysis of the control charts showed that all results are within specifications and vidas b.R.A.H.M.S pct batch 1009004570 is in the trend compared to the other lots.Analysis of results obtained during cap survey challenge.Complaints laboratory subscribes to the same proficiency testing program as the customer uses.The quality control samples of campaign pct a 2022 were also tested in march 2022 but using another lot of vidas b.R.A.H.M.S pct (lot 1009094460).All the results of the different samples (pct-01, pct-02 and pct-03) were within the acceptable ranges and close to the peer group mean including pct-01.Test on internal samples.The complaints laboratory tested 3 internal samples (targets at 3.03 / 7.80 and 10.7 ng/ml) using retained samples from the customer's lot 1009004570.The results complied with the specifications, without any significant difference compared to those observed before the batch release.No evolution was observed over time of these samples activity.The internal sample with the target at 10.7 ng/ml was also tested on vidas b.R.A.H.M.S pct lot 1009094460 (lot used during the challenge of cap survey pct a 2022).The result was within range without significant difference compared to those obtained at different time using vidas b.R.A.H.M.S pct lot 1009004570 (customer¿s lot).Test on quality control sample.Biomérieux complaints laboratory tested another quality control sample from a french provider of proficiency testing program, in order to check if the behavior of quality control sample is different from natural samples.The results observed on the lots of vidas b.R.A.H.M.S pct (customer¿s lot 1009004570 and the second lot 1009094460) were both within the acceptable range mentioned by the provider without significant difference between the lot used by the customer batch 1009004570 (14.68 ng/ml) and another lot 1009094460 (13.91 ng/ml).Conclusion.The complaints laboratory did not reproduce the issue reported by the customer (result too high) when testing internal samples on vidas b.R.A.H.M.S pct lot 1009004570.The result obtained when testing an internal sample (with a target close to the concentration of pct-01) on 2 lots of vidas b.R.A.H.M.S pct including the customer¿s lot were similar and within acceptable range.Any significant difference was observed between the result obtained with lot 1009004570 (customer¿s lot) and the second lot when testing another quality control sample, both results were within range.Without the concerned quality control sample (pct-01), it is not possible to investigate further.No obvious root cause was identified.The issue could have a multifactorial root cause combining: -a matrix effect of the quality control from cap survey (e.G: manufacturing with a recombinant procalcitonine 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 quality control sample processed by the customer (e.G stability, homogenization, and handling).The instrument (respect of instructions of use related to preventive maintenance and monitoring with weekly qcv testing).The calibration results.The required maintenances (user maintenance and preventive maintenance) is important in order to maintain instrument performances.According to the data mentioned above, there is no reconsideration of the vidas b.R.A.H.M.S pct lot 1009004570.

• Brand Name: VIDAS® BRAHMS PCT ¿
• Type of Device: VIDAS® BRAHMS PCT ¿
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer Contact: candace martin ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 14217180
• MDR Text Key: 299380160
• Report Number: 8020790-2022-00052
• 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: 06/15/2022

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: 03/28/2023
• Device Model Number: 30450-01
• Device Catalogue Number: 30450-01
• Device Lot Number: 1009004570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/27/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1