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

Catalog Number 30450-86

Device Problem Nonstandard Device (1420)

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

Event Type  malfunction  

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.

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¿ (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) 2022, a customer in (b)(6) notified biomérieux of substrate error leading to potential delayed results when testing with vidas® brahms procalcitonin 60t (ref.30450, lot #1008817120) with two patient samples.With a substrate error, an error message is displayed on the equipment visible by the user, and it is impossible to run tests and generate results.The problem started as soon as i opened the box.The customer mentioned a delay, however the length of the delay is not known as well as the number of impacted patients.The lot impacted in this complaint is part of the scope of fsca #5333 for substrate error on multiple vidas product references that was released on 22-sep-2021.A biomérieux internal investigation has been initiated.Note: reference 30450-86 is not registered in the united states.The u.S.Similar device is product reference 30450-01.

• 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: romain marti ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 14396100
• MDR Text Key: 293337321
• Report Number: 8020790-2022-00057
• Device Sequence Number: 1
• Product Code: PRI
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K162827
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2023
• Device Catalogue Number: 30450-86
• Device Lot Number: 1008892830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 5333
• Patient Sequence Number: 1