MAUDE Adverse Event Report: BIOMERIEUX 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

On (b)(6) 2022, a customer from hungary notified biomérieux of obtaining potential false overestimated result when testing patient samples with vidas brahms procalcitonin 60t (ref.30450, batch number: 1009216670, expiry date: 20-jul-2023).This lot was opened on (b)(6) 2022.On (b)(6) 2022, 60.69 was the result for a baby born on (b)(6) 2022.On (b)(6) 2022, the result was 6.3.The condition of the patient improved soon.The patient received bolus infusion and imipenem therapy.Carbapenem was also administered for a while.Patient had tachycardia.According to clinician the pct results are not in accordance with patient status.Based on the available information at the time of this assessment, there is no indication or report from the laboratory that the issue led to any adverse event related to patient's state of health.A biomérieux internal investigation has been initiated.Note: reference 30450 is not registered in the united states.The u.S.Similar device is product reference 30450-01.

Manufacturer Narrative

A biomérieux internal investigation has been completed with the following results: investigation: device history record.The review did not highlight any issue during manufacturing, control and packaging processes for vidas brahms pct ref 30450 lot: 1009216670.There was no capa, no non conformity on vidas brahms pct ref 30450 linked to customer 's complaint.Complaint analysis.To date, no similar complaint have been registered on the kit vidas brahms pct ref: 30450 lot: 1009216670.Test/analysis performed.Customer¿s material: there was no remaining patient samples at the time of the complaint.The investigation was performed with internal samples.Control charts analysis: the complaints laboratory analyzed the results of five (5) internal samples targeted between 0.08 ng/ml and 118 ng/ml, on nine (9) different batches of vidas brahms pct ref 30450 including customer¿s lot: 1009216670 and another lot: 1009072010.The analysis of the control charts showed that all results were within specifications.The customer¿s lot was in the trend of the other lots.Tests performed by complaint laboratory.On internal samples: the complaints laboratory tested four (4) internal samples with concentrations distributed at different level of vidas brahms pct curve (targets 0.08, 0.30, 1.22 and 67.8 ng/ml) with the retain kits vidas brahms pct 1009072010, 1009216670, and another batch for comparison 1009462790.All samples results were within their expected specifications.For vidas brahms pct batch: 1009216670 , a non-reproducible result (1 result /3) was out of specification due to a pre-analytical issue.After another centrifugation, the results were reproducible and complied to vidas brahms specification.Package insert information.Chapter sample preparation.¿the pre-analytical step, including the preparation of blood samples, is an essential first step when performing medical analyses.In accordance with good laboratory practice, this step is performed under the responsibility of the laboratory manager.Insufficient clot time can result in the formation of fibrin with micro-clots that are invisible to the naked eye.The presence of fibrin, red blood cells, or suspended particles can lead to erroneous results.Samples containing suspended fibrin particles or erythrocyte stroma should be centrifuged before testing.For serum specimens, ensure that complete clot formation has taken place prior to centrifugation.¿ there was no significant evolution over time of the batch mentioned by the customer since the batch was released.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 1009072010 and 1009216670 using internal samples.The customer¿s issue of overestimated results was not reproduced by complaints laboratory during the investigation conducted on internal sample materials.The investigation did not manage to identify any obvious root cause.Without a return of customer¿s 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 30450, 1009216670.

• Brand Name: VIDAS® B¿R¿A¿H¿M¿S PCT¿
• Type of Device: VIDAS® B¿R¿A¿H¿M¿S 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: danielle cooper ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 15089289
• MDR Text Key: 304807202
• Report Number: 8020790-2022-00084
• Device Sequence Number: 1
• Product Code: PRI
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2023
• Device Catalogue Number: 30450
• Device Lot Number: 1009216670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1