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

Catalog Number 30450

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomerieux of false low pct results for a patient sample associated with the vidas® brahms procalcitonin 60t test kit (reference 30450, lot 1007294400).The customer stated the patient sample was retested following a qcv detected failure in section a of the vidas® instrument.The original result was 8.43ng/ml, the retest yielded a result of <0.05ng/ml.The sample was sent to a reference laboratory for testing and obtained a result of 8.43ng/ml.There is no patient impact, the customer confirmed the result of 8.43ng/ml was reported to the treating physician.Biomerieux will initiate an internal investigation.Reference 30450 is not registered in the united states.The u.S.Similar device is product reference (b)(4).

Manufacturer Narrative

This report was initially submitted following notification from a customer in south africa regarding false low pct results for a patient sample associated with the vidas® brahms procalcitonin 60t test kit (reference 30450, lot 1007294400).The customer stated the patient sample was retested following a qcv detected failure in section a of the vidas® instrument.The original result was 8.43ng/ml, the retest yielded a result of <0.05ng/ml.The sample was sent to a reference laboratory for testing and obtained a result of 8.43ng/ml.Reference 30450 is not registered in the united states.The u.S.Similar device is product reference 30450-01.A biomérieux internal investigation has been completed with the following results: investigation results customer's material the customer's samples were not returned.Batch history records and trend analysis no non-conformity and no capa linked to the customer's complaint recorded on vidas brahms procalcitonin ref 30450 lot 1007294400.The batch history records shows no anomaly during the manufacturing, control and packaging processes.**study of internal samples control charts** analysis of four (4) internal sera from adjustment panel: pa121 [0.06 - 0.18] ng/ml target 0.12 ng/ml pa102 [0.27 - 0.51] ng/ml target 0.39 ng/ml pa118 [6.02 - 9.42] ng/ml target 7.72 ng/ml pa116 [8.33 - 13] ng/ml target 10.7 ng/ml this analysis was carried out on seven (7) lots of vidas pct including the customer's lot : 1007294400.All the results were within specifications and the customer's lot was in the trend of the other lots.Conclusion: there was no anomaly highlighted with the control chart and the analysis of quality data performed on the lot vidas brahms procalcitonin ref 30450 1007294400.Vidas pct lot 1007294400 is within its specifications.Performances of vidas pct 1007294400 / 200726-0 are within specifications.

• 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
• 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 ; 3145068201
• MDR Report Key: 9298662
• MDR Text Key: 219202124
• Report Number: 8020790-2019-00066
• Device Sequence Number: 1
• Product Code: PRI
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2020
• Device Catalogue Number: 30450
• Device Lot Number: 1007294400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1