MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® BRAHMS PROCALCITONIN 60T - 30450-01

Model Number 30450-01

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer.

Event Description

A customer in the united states notified biomérieux of obtaining a bad correlation result between two lots of vidas® brahms procalcitonin 60t (ref.30450-01 lots, 1007419860 and 1007448940).The customer stated that they obtained discrepant results while performing a ¿crossover¿ test between the current lot (1007419860) and the new lot (1007448940) of vidas ® brahms procalcitonin.The results were as follows: sample 1 lot 1007419860: pct result = 69 ng/ml; sample 1 lot 1007448940: pct result = 48 ng/ml; sample 2 lot 1007419860: pct result = 0.46 ng/ml; sample 2 lot 1007448940: pct result = 0.34 ng/ml; sample 3 lot 1007419860: pct result = 0.13 ng/ml; sample 3 lot 1007448940: pct result = 0.09 ng/ml.Per the ranges listed in the vidas® brahms procalcitonin 60t ifu the interpretation of sample 1 changed from ¿> 0.50 ng/ml suggestive of presence of bacterial infection.Antibiotic therapy strongly recommended¿ to ¿ results between 0,26-0,50 ng/ml bacterial infection is possible.Antibiotic therapy recommended.¿ 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.

Manufacturer Narrative

This report was initially submitted following a notification from a customer in the united states regarding a bad correlation result in association with the vidas® brahms procalcitonin (pct) assay.Biomérieux conducted an internal investigation; there was no return kit or specimen available from the customer.The investigation included a review of batch history capa and non-conformities and testing with internal samples.Review of the manufacturing and qc batch records of lot 1007448940 showed no anomaly recorded during the manufacturing and control processes.This review showed no capa nor non-conformities related to bad correlation results.Testing was performed with four (4) internal samples using retained customer lot 1007448940 and challenge lot 1007419860.All results obtained were within the expected range; no discrepancies were noted between the two lots.The customer¿s anomaly was not reproduced.The investigation concluded that vidas® brahms procalcitonin ref (b)(4), batch number 1007448940 is performing as expected.See section h10.

• Brand Name: VIDAS® BRAHMS PROCALCITONIN 60T - 30450-01
• Type of Device: VIDAS® BRAHMS PROCALCITONIN 60T - 30450-01
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• MDR Report Key: 9505764
• MDR Text Key: 219779416
• Report Number: 8020790-2019-00074
• Device Sequence Number: 1
• Product Code: PRI
• UDI-Device Identifier: 03573026223601
• UDI-Public: 03573026223601
• Combination Product (y/n): N
• PMA/PMN Number: K162827
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

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 Expiration Date: 12/16/2020
• Device Model Number: 30450-01
• Device Catalogue Number: 30450-01
• Device Lot Number: 1007448940
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/23/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1