MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® BRAHMS PROCALCITONIN; VIDAS® BRAHMS PCT

Catalog Number 30450

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2018

Event Type  malfunction  

Event Description

A customer in (b)(6) reported a falsely underestimated result in association with the vidas® brahms procalcitonin assay.The customer stated the initial test did not give the correct result based on the background reading, rfv, and patient condition, and that the repeat test was consistent with the patient's critical condition with sepsis.The patient had a positive blood culture on (b)(6) 2018, and pct was run on (b)(6) 2018.The customer mentioned they found a stuck solid phase receptacles (spr®) at the end of the initial run.Position a1 - initial test: background reading : 23, sample rfv: -9, result (ng/ml): < 0.05.Position b1 - repeat test: background reading : 169, sample rfv: 763, result (ng/ml): 15.12.The customer reported that there was no impact to patient treatment as the repeat result which was consistent with the blood culture positive result, was reported to the physician.It was reported that the patient condition improved and they were discharged.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following a report from a customer in malaysia regarding a falsely underestimated result in association with the vidas® brahms procalcitonin (pct) assay.Biomérieux investigation was conducted; there was no return kit or specimen available from the customer.Evaluation of the manufacturing qc batch records indicated the following: no capa nor non-conformity linked to the customer's complaint recorded on vidas b·r·a·h·m·s pct¿ parameter (ref.30450).Analysis of the batch history records: no anomaly recorded during the manufacturing and control processes; control charts analysis: all results are conform to expected specification and well targeted on this batch; no other similar complaint on this batch number 1006397040/190321-0.Tests performed: without return sample available, testing of the internal samples on the retained (in house) kit was performed.All tests conformed to expected specifications; on all the spr® observed on the batch 1006397040/190321-0 , no anomaly was detected; on all test variations performed in order to try to reproduce the customer anomaly, only a badly positioned strip could give a very low background noise reading and lower result than expected.Review of instructions for use [mini vidas user manual (161150-637-b)]: (5-23): "loading reagent strips and solid phase receptacles (spr®).Caution: make sure the strip is firmly placed by sliding it all the way until you feel the strip lock into the section channel.Caution: when placing the spr® in the spr® block position, do not apply pressure to the block position as this may cause the spr® to be ejected." (5-25): "important: when unloading the reagent strips and solid phase receptacles (spr®), carefully read the precautions described in precautions for use of reagents on page 2-11, section «at the end of the run».(2-11): do not use visibly deteriorated strips (damaged foil or plastic) or if reagents are leaking, as this could affect the accuracy of test results." the investigation concluded that vidas brahms procalcitonin ref 30450, batch number 1006397040/190321-0 (exp.21 mar 2019) is performing as expected.

• Brand Name: VIDAS® BRAHMS PROCALCITONIN
• Type of Device: VIDAS® BRAHMS PCT
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280, ; FR
• MDR Report Key: 8133944
• MDR Text Key: 130061252
• Report Number: 3002769706-2018-00250
• Device Sequence Number: 1
• Product Code: PRI
• Combination Product (y/n): N
• PMA/PMN Number: K162827
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2019
• Device Catalogue Number: 30450
• Device Lot Number: 1006397040
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1