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

Model Number 30450-01

Device Problem Unable to Obtain Readings (1516)

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

Event Type  malfunction  

Event Description

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 substrate error when testing with vidas® b·r·a·h·m·s pct¿ (ref.30450-01, lot # 1008748010) with patient samples.An error message is displayed on the equipment visible by the user, and it is impossible to run tests and generate results.The customer did specify a delay of about eight (8) hours in reporting results for 10 patients.They have had to send samples to a sister lab for testing.Impacted lot by this complaint is in the scope of fsca 5333 issued on 22-sep-2021 on multiple vidas references for substrate error.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

Since july 2021, biomérieux has been receiving an increasing number of complaints linked to a vidas® ¿substrate error¿.It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.A measurement of the background noise signal (rfu) is made by the vidas® system prior to launching the reaction.An acceptable limit is defined during product design for each reference of finished goods.Three values exist as acceptable limits depending on the assay: 300, 350 and 500 rfu.The substrate is present in the last well of the strip of all vidas® immuno-assays and allows fluorescence when degraded by the enzyme (pal).The level of fluorescence is then correlated with the results of all tests.When performing a test, if the rfu is higher than the acceptable limit defined during the product development, there is an error message displayed by the system: ¿substrate error¿.The test is stopped and this alarm prevents the system from providing any result.With this alarm being present on all the systems of the vidas® family, it guarantees that no false results can be given in case of a substrate degradation.There is a potential risk of delayed results.Description of the investigation and root cause analysis : investigations were immediately initiated to identify the root-cause, the following were identified: all lots impacted of vidas® immuno-assays were conform to the specifications at release.The substrate error issue was confirmed on all lots of vidas® immuno-assays manufactured with substrate batches using a common lot of raw material (4-mup) that was identified as the most probable common root-cause.The scope of the issue was identified on all lots of vidas® immuno-assays manufactured since february 2021 using substrate batches manufactured with this concerned lot of raw material.The problem is due to an accelerated degradation of the substrate.It follows a linear model over time leading to rfu acceptable limits being reached before the end of the registered shelf life of the product.Kinetic evolution analyses were performed by measuring substrate rfu of a statistically representative number of vidas® immuno- assays retained batches (manufactured with the substrate containing the concerned raw material) at different shelf-lives.The model was validated on numerous data approximately (450 000) collected from the field (customers).The analysis of the kinetic model allows us to predict the degradation trend of the substrate using the concerned batch of 4mup and therefore to revise the expiry dates for each lot of impacted vidas® immuno- assays finished products.When used until the revised expiry date, the product continues to perform per its registered performance specifications.When an error message ¿substrate error¿ is displayed by the vidas® system, the test is stopped and this alarm prevents the system from providing any result.The inability to provide a result in a timely manner (potential delayed results) may have an impact on patient management depending on: whether or not there are clear management or treatment strategies that rely solely or mostly on the test result; whether or not the management strategy can be delayed, and for how long; whether or not there are assays from a lot not impacted by the issue that are available; whether or not the laboratory is able to use an alternative method.Therefore, a corrective action involving a revised expiration date for all impacted lots of clinical vidas® immuno-assays products is required to ensure that the specified products will continue to perform per labelled performance specifications.The investigation is ongoing.

Manufacturer Narrative

Following an increase in customer complaints about ¿substrate error¿ on different vidas® references tested on all vidas systems, an internal investigation was performed.Investigation device history record: the analysis of the batch history records of the vidas lots concerned showed no anomaly during the manufacturing, control, and packaging processes.No non-conformity linked to the customer¿s complaint was registered on these batches.Following the increase of complaints for substrate issues, a capa (corrective action preventive action) has been opened to identify the actions.Tests/analysis performed: - the problem was detected on vidas, when the fluorescence is measured (first read) before the beginning of the tests.If there is a ¿substrate error¿, the user has an error message ¿ errors/substrate error¿ which displays on the equipment making it impossible to run tests and generate results.- the ¿substrate error¿ issue has been observed 5 to 6 months after the date of manufacturing of the strips.- during the investigation, it was confirmed that one lot of common raw material was used in all substrate batches contained in vidas® immuno-assays strips with a high level of complaints about ¿substrate error¿ and therefore this batch of raw material was identified as the most probable common root-cause.- investigation performed at the supplier level confirmed that a lot of raw material in cause is atypical and is indeed the source of substrate errors on vidas reagents.- at the end of september 2021, the manufacturing site stopped the production of the kits with the concerned raw material lot.Root cause analysis and conclusion: - the root causes linked to the specifications process at the supplier of the raw material have been identified.- corrective action will be implemented at the supplier to add some specifications and control in the manufacturing process of the raw material concerned.- at biomérieux site, an incoming control with stability will be implemented as a preventive action.

• Brand Name: VIDAS® BRAHMS PROCALCITONIN 60T
• Type of Device: VIDAS® BRAHMS PROCALCITONIN 60T
• 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: 13057710
• MDR Text Key: 290404290
• Report Number: 8020790-2021-00386
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2022
• Device Model Number: 30450-01
• Device Catalogue Number: 30450-01
• Device Lot Number: 1008748010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FSCA 5333
• Patient Sequence Number: 1