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

Catalog Number 30450-01

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in the united states reported that they obtained a false low result for their cap survey sample, using the vidas® brahams procalcitonin (pct) assay, lot 1006974220.The customer stated the qc was within range using kit controls.S1 rfv was 2077 (range 1748 - 3122; mean 2435); s2 rfv 424 (range 292 - 521; mean 406.5); c1 18.10 ng/ml (range 12.95 - 20.23ng/ml); c2 1.86 ng/ml (range 1.33 - 2.15 ng/ml); qc result of 5.64 ng/ml ( expected value range was 6.21 - 8.56 ng/ml).According to the cap survey report: pct-01 : customer s result 5.64 ng/ml peer group mean = 7.386 ng/ml range [6.21-8.56] => out of range too low; pct-02 : customer s result < 0.05 ng/ml not evaluated; pct-03 : customer s result 1.96 ng/ml peer group mean = 2.240 ng/ml range [1.86-2.67].A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal investigation was performed for a false low result for a cap survey sample, using the vidas® brahms procalcitonin (pct) assay, lot: 1006974220.Customer's material: no customer's material was received for investigation.Quality control records: no capa nor non conformity linked to the customer's issue was recorded on vidas brahms procalcitonin reference: (b)(4), lot: 1006974220 / 191127-0.Analysis of the batch history records showed no anomaly during the manufacturing, control and packaging processes on lot vidas brahms procalcitonin reference: (b)(4), lot: 1006974220 / 191127-0.Study of internal samples control charts : complaint laboratory observed 4 internal sera (targets 1.22 g/l ; 7.72 g/l ; 10.7 g/l; 0.30 g/l) on 9 lots of vidas brahms procalcitonin including customer's lot: (191127-0).All results were within specifications and the customer's lot was in the trend of the other lots.Complaint analysis : no other complaint was registered on the same external quality control cap survey pct a01.Tests performed in complaint's laboratory: complaint laboratory tested 4 internal samples (same as above) on retain kit vidas brahms procalcitonin reference: (b)(4), lot: 1006974220 / 191127-0.Results were within specifications and close to the values obtained before batch release.There was no drift of the batch since its release.Conclusion: customer's issue was not reproduced.According to all the data above, vidas brahms procalcitonin reference: (b)(4), lot: 1006974220 / 191127-0 performed as intended.

• Brand Name: VIDAS® BRAHAMS PROCALCITONIN
• Type of Device: VIDAS® BRAHAMS PCT
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280, ; FR
• MDR Report Key: 8669246
• MDR Text Key: 213479409
• Report Number: 8020790-2019-00031
• Device Sequence Number: 1
• Product Code: PRI
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

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: 11/27/2019
• Device Catalogue Number: 30450-01
• Device Lot Number: 1006974220
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2019
• Initial Date FDA Received: 06/04/2019
• Supplement Dates Manufacturer Received: 08/14/2019
• Supplement Dates FDA Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1