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

Catalog Number 30450-01

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

Patient Problem No Patient Involvement (2645)

Event Date 09/03/2018

Event Type  malfunction  

Event Description

A customer in the united states contacted biomérieux to report the occurrence of a (b)(6) sample out of range (result was 1.49ng/ml, acceptable range 1.56 - 2.30ng/ml) for the vidas brahms procalcitonin (pct) assay.Repeat testing obtained results of 1.42 and 1.30 ng/ml.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to the patient's state of health.There was no patient associated with the cap survey sample.Biomérieux investigation will be conducted.

Manufacturer Narrative

An internal investigation was performed for a cap survey sample (1374401-01) that was out of range low (1.49ng/ml) compared to the acceptable range (1.56 - 2.30ng/ml) for the vidas brahms procalcitonin (pct) assay.** quality control records** no capa nor non-conformity was linked to the customer's issue for vidas pct, ref.30450-01, lot number 1006455600.** batch history record** no anomaly during the manufacturing , control and packaging processes ** study of internal samples control charts ** : four internal sera were tested on five batches of vidas pct including the one of the customer.All results are within specifications.The customer's lot was in the trend of the other lots.**complaint analysis** no other similar complaint was recorded for an underestimated result with this eqa program (cap).**tests performed internally ** (1 ng/ml = 1 ¿g/l) cap survey pct-b 2018 campaign aug 2018: 604 laboratories using vidas gave a result for sample pct-06 cap survey complaint laboratory results : pct-06 sample vidas pct lot 190326-0: 2.02 [?]g / l vidas peer group average 1,929 [?]g / l - (min at 1,56 [?]g / l -max at 2,28 [?]g / l) feb 2019 investigation : cap survey pct-06 thawed sample: vidas pct tested with pct lot 190412-0 : 1.84 [?]g / l value close to the target and conforms to the vidas peer group acceptable ranges.Feb 2019 complementary tests on internal sample pa112 from activity panel: pa112: 3.71 [?]g / l acceptable range [3.39-5.33] [?]g / l release value 4.02 [?]g / l pa112 conforms and cis lose to the value obtained during the activity check conclusion the customer's anomaly was not reproduced.Sample cap survey pct-06 was tested in aug 2018 (lot 190326-0) and checked in feb 2019 on the customer's batch (vidas pct lot 1006455600 / 190412-0).Both results are close to the target and conform to vidas peer group acceptable ranges.According to the information/data mentioned above, the kit vidas pct lot 1006455600 / 190412-0 is within the expected performances.

• 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: 8317462
• MDR Text Key: 136343160
• Report Number: 8020790-2019-00008
• Device Sequence Number: 1
• Product Code: NTM
• UDI-Device Identifier: 03573026223601
• UDI-Public: 03573026223601
• Combination Product (y/n): N
• PMA/PMN Number: K071146
• 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: 04/01/2019

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: 04/12/2019
• Device Catalogue Number: 30450-01
• Device Lot Number: 1006455600
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2018
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: 03/06/2019
• Supplement Dates FDA Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1