MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS BRAHMS PROCALCITONIN 60T; VIDAS® BRAHMS PROCALCITONIN 60T

Catalog Number 30450

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Note: reference 30450 is not registered in the united states.The u.S.Similar device is product reference 30450-01.A customer from (b)(6) notified biomérieux of obtaining 2 falsely under estimated procalcitonin results in association with the vidas® brahms procalcitonin 60t tests (ref.30450, lot 1008130900) when testing 2 separate samples.The customer obtained the following results: test 1: sample (b)(6): value < 0.05 ng/ml.Sample (b)(6): value < 0.05 ng/ml.Test 2: sample (b)(6): value = 52.46 ng/ml.Sample (b)(6): value = 2.25 ng/ml.The customer confirmed the minividas® instrument used to test the sample passed weekly qcv testing.The initial results of < 0.05 ng/ml indicated the sample cones may have been missing from both initial tests.Local customer service required the customer to count the sample cones; however, this information has not been provided.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.Biomerieux will initiate an internal investigation.

Manufacturer Narrative

This report was initially submitted following notification from a customer in brazil regarding two (2) falsely under-estimated procalcitonin (pct) results in association with the vidas® brahms procalcitonin 60t tests (ref.(b)(4) , lot 1008130900) when testing two (2) separate samples.The customer¿s samples were not available to be submitted for the investigation.According to the analysis of the quality data, no anomalies were identified during the manufacturing, control and packaging processes for vidas® brahms pct ref (b)(4) batch 1008130900/ 211206-0.The investigation unit laboratory tested six (6) internal samples on the retain kit of vidas® brahms procalcitonin ref (b)(4) lot 1008130900 / 211206-0.The results of the samples complied with the standards, and were close to the results obtained during the release of the lot.There was no drift of the lot identified.The customer¿s initial results of <0.05 ng/ml indicated the sample cones (spr - solid phase receptacle) may have been missing from both initial tests.Local customer service required the customer to count the sample cones; however, this information has not been provided.The root cause of the complaint could not be determined.Based on internal data and information provided by the customer, a potential root cause of the complaint is operator error linked to the absence of the spr.There is no reconsideration of the performance of product vidas® brahms pct ref (b)(4) batch 1008130900/211206 to its expectations.

• Brand Name: VIDAS BRAHMS PROCALCITONIN 60T
• Type of Device: VIDAS® BRAHMS PROCALCITONIN 60T
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• MDR Report Key: 11374776
• MDR Text Key: 269877678
• Report Number: 8020790-2021-00015
• 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: 04/21/2021

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: 12/06/2021
• Device Catalogue Number: 30450
• Device Lot Number: 1008130900
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 03/25/2021
• Supplement Dates FDA Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1