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

Catalog Number 30450

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Event Description

Product description: vidas® brahms pct¿ is an automated test for use on the vidas® family of instruments for the determination of human procalcitonin in human serum or plasma (lithium heparin) 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¿ aids in the risk assessment of critically ill patients on their first day of icu admission, for progression to severe sepsis and septic shock.Used in conjunction with other laboratory findings and clinical assessments, vidas® b·r·a·h·m·s pct¿ also aids in decision making on antibiotic therapy for patients with lower respiratory tract infections (lrti) (including community acquired pneumonia, exacerbation of chronic obstructive pulmonary disease, acute bronchitis) seen during medical consultations, including at the emergency department.Issue description: on 24-oct-2022, a customer in tunisia notified biomérieux of obtaining an over-estimated result (4.60 ng/ml) when using vidas brahms procalcitonin 60t reference 30450 lot 1009126790 (expiry 04-jun-2023).There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.Note: reference 30450 is not sold or distributed in the united states.However, there is a similar device, product reference, 30450-01.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal investigation was performed following notification from a customer in tunisia of observing an over-estimated result (4.60 ng/ml) when using vidas brahms procalcitonin 60t reference (b)(4) lot 1009126790 (expiry 04-jun-2023).Investigation 1.Device history record the review did not highlight any issue during manufacturing, control and packaging processes for vidas brahms pct reference (b)(4) lot 1009126790.1.Complaint analysis the analysis of complaints did not reveal a systemic quality issue.2.Test/analysis performed customer¿s material there was no remaining patient samples at the time of the complaint.The investigation has been performed with internal samples.Control charts analysis the complaints laboratory analyzed the results of four (4) internal samples with target at 0.34 ng/ml; 0.49 ng/ml ; 1.22 ng/ml and 3.92 ng/ml, on five (5) different batches of vidas brahms pct reference (b)(4) including customer¿s lot 1009126790.The analysis of the control charts showed that all results are within specifications.Customer¿s lots are in the trend of the other lots.Tests performed by complaint laboratory on internal samples: the complaints laboratory tested three (3) internal samples with target at 0.34 ng/ml ; 0.49 ng/ml and 1.13 ng/ml with the retain kit vidas brahms pct (b)(4).All samples results are within their expected specifications.Moreover results are similar to those obtained during the quality control of batch.There is no drift of kit vidas brahms pct reference (b)(4) lot 1009126790 since its release.External quality sample analysis the complaint laboratory (iu) subscribes to different eqc campaigns, including the one of the french supplier probioqual.The analysis of report from two (2) samples, shows that results between vidas peer group and roche peer groups are quite similar.The difference observed by customer on his patient samples is not reproduced during the external quality campaign.4.Root cause analysis and conclusion according to all information above, no anomaly was highlighted with the control chart analysis, the analysis of quality data and the tests performed on retain kit vidas brahms pct (b)(4) using internal samples.Customer¿s issue, ie overestimated results, were not reproduced by complaints laboratory during the investigation conducted on internal samples materials.The investigation did not manage to identify any obvious root cause.Without customer¿s return sample and kit, further investigation cannot be pursued.According to the package insert, in the chapter range of expected values ¿ risk assessment for progression to severe sepsis and septic shock: in agreement with the literature (3, 4), the results obtained with vidas®b¿r¿a¿h¿m¿s pct¿ during a study performed on patients admitted to intensive care units (refer to the "clinical performance" section) are as follows: a concentration < 0.5 ng/ml represents a low risk of severe sepsis and/or septic shock.A concentration > 2 ng/ml represents a high risk of severe sepsis and/or septic shock.Nevertheless, concentrations < 0.5 ng/ml do not exclude an infection, on account of localized infections (without systemic signs) which can be associated with such low concentrations, or a systemic infection in its initial stages (< 6 hours).Furthermore, increased procalcitonin can occur without infection.¿ there is no reconsideration of the performance of vidas brahms pct ref (b)(4).

• 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 road; hazelwood, MO 63042
• MDR Report Key: 15821671
• MDR Text Key: 304218630
• Report Number: 8020790-2022-00108
• Device Sequence Number: 1
• Product Code: PRI
• Combination Product (y/n): N
• Reporter Country Code: TS
• 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: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2023
• Device Catalogue Number: 30450
• Device Lot Number: 1009126790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1