MAUDE Adverse Event Report: BIOMÉRIEUX SA VIDAS® BRAHMS PCT¿

Catalog Number 30450

Device Problems High Test Results (2457); Non Reproducible Results (4029)

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

Event Type  malfunction  

Event Description

On (b)(6) 2023, a customer in south africa notified biomérieux of overestimated results when testing 2 patients¿ samples with vidas brahms procalcitonin 60t (ref.30450, lot# 1009791810, expiry date: 05-jun-2024).Clinical information (unspecified patient #): on (b)(6) 2023, fungitell positive.On (b)(6) 2023: - clostridium tertium identified - c reactive protein (crp) 181 treated by antibiotics including meropenem.Tests of patient sample diluent: crp 1 - pct 0.05 the customer indicated differences in the pct values obtained when using 2 different negative patient samples as diluents: - patient 1 o diluent 1: 62.83 ng/ml o diluent 2: 262.53 ng/ml - patient 2 o diluent 1: 223.25 ng/ml o diluent 2: 552.80 ng/ml of note, on (b)(6) 2023, the quality control of vidas (qcv) was performed and no anomalies on the instrument were detected.At the time of this assessment, there was no indication or report from the customer that the issue led to any adverse event related to the patient's state of health nor delay in rendering the results.A biomérieux internal investigation will be initiated.Note: reference 30450 is not registered in the united states.The u.S.Similar device is product reference: 30450-01.

Manufacturer Narrative

This report was initially submitted following notification from a customer in south africa regarding overestimated results when testing two (2) patients¿ samples with vidas® brahms procalcitonin 60t (ref.30450, lot# 1009791810, expiry date: 05-jun-2024).A biomérieux internal investigation has been completed with the following results: device history record: the review did not highlight any issue during manufacturing for this lot number (vidas brahms pct ref 30450 lot 1009791810).Complaint analysis: until now, no similar complaint has been recorded on vidas brahms pct ref 30450 lot 1009791810.Tests/analysis performed **control chart analysis ** this analysis was carried out: - on four (4) internal samples with a respective target at 10.9 ng/ml, 67.8 ng/ml, 121 ng/ml and 154 ng/ml - on seven (7) batches of vidas brahms pct ref 30450 including lot 1009791810 mentioned by the customer.The analysis of the control charts showed that all results were within specifications and vidas brahms pct ref 30450 lot 1009791810 is in the trend compared to the other lots.****test on internal samples** analyses were performed on the retain kit vidas brahms pct ref 30450 lot 1009791810.The customer's samples were not available for testing.The investigation unit laboratory tested four (4) internal samples (target at 0.88 ng/ml, 67.79 ng/ml, 121.14 ng/ml, 153.69 ng/ml) the results complied with the specifications without any significant difference compared to the results observed before the batch release.No evolution over time was observed for these samples' activity.**dilution tests** ~~~~~~~~~~~~~~~~~~~~~~~~ the investigation unit laboratory performed dilution at 1:10 on high internal serum with concentration > 200 ng/ml in a serum free (ref 50020794) and in negative samples from etablissement français du sang (efs) as recommended in the ifu.Regardless of the diluent used, the results were homogeneous and consistent 219.9 to 230.2 ng/ml root cause analysis and conclusion: the investigation did not manage to identify any obvious root cause.The investigation unit laboratory did not reproduce the customer¿s anomaly on kit vidas brahms pct ref 30450 lot 1009791810.All the results complied with their specifications (internal samples) or were in accordance with expectations when performing dilution.There is no reconsideration of the performance of product kit vidas brahms pct ref 30450 lot 1009791810 to its expectations.

• Brand Name: VIDAS® BRAHMS PCT¿
• Type of Device: VIDAS® BRAHMS 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: danielle cooper ; 595 anglum rd; hazelwood, MO 63042
• MDR Report Key: 17300556
• MDR Text Key: 319703498
• Report Number: 8020790-2023-00038
• Device Sequence Number: 1
• Product Code: PRI
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

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 Catalogue Number: 30450
• Device Lot Number: 1009791810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 07/21/2023
• Supplement Dates FDA Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1