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

Catalog Number 30450

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A customer from (b)(6) notified biomérieux of obtaining low results when performing internal quality control with vidas® brahms procalcitonin 60t (ref.30450, batch 1008527010, expiry date: 14jul2022).(b)(6).The customer performed the calibration three times and all times were valid.On the next day, the customer tested opro 1 on a previous batch of vidas brahms procalcitonin 60 (batch 1008554150) and the results were in the normal ranges.There is no patient associated with this internal quality control; therefore, there is no adverse event related to any patient's state of health.At the time of this assessment, biomerieux is not aware of any impact on patient results.A biomérieux internal investigation has been initiated.Note: reference 30450 is not registered in the united states.The u.S.Similar device is product reference 30450-01.

Manufacturer Narrative

The concerned quality control samples used are lyphocheck specialty lot 25291, thermofisher id (b)(4).2- investigations: ************************* 3-1) device history record: ----------------------------------- the review did not highlight any issue during the manufacturing, control and packaging processes of b.R.A.H.M.S pct lot 1008527010.3-2) complaint analysis: ------------------------------------------ the complaint analysis did not reveal this issue as a systemic quality issue.3-3) tests performed by the complaints laboratory --------------------------------------------------------------------- customer material: **quality control samples received from the customer: -bio-rad lyphocheck lot 25291.-thermofisher id (b)(4).** kit of vidas b.R.A.H.M.S pct lot 1008527010 already opened.Control chart analysis: analysis conducted on - 4 internal samples with a respective target at 0.30 / 0.34 / 3.03 / 3.92 ng/ml.- for 7 lots of vidas b.R.A.H.M.S pct included the batch mentioned by customer (1008527010).All the sample results complied with the expectations and vidas b.R.A.H.M.S pct lot 1008527010 is in the trend compared to the other lots with results close to the targets.Tests performed on internal samples: the complaints laboratory tested 3 samples with respective targets at 0.30 / 0.34 / 3.03 ng/ml on vidas b.R.A.H.M.S pct lot 1008527010 (retain kit/ customer¿s lot) and vidas b.R.A.H.M.S pct lot 1008554150 (retain kit, reference lot).The results were compliant to the expectations, similar on both lots and the results obtained on vidas b.R.A.H.M.S pct lot 1008527010 were similar to those obtained before the batch release.We do not observe any evolution over time of vidas b.R.A.H.M.S pct lot 1008527010.Tests performed on quality control from bio-rad.The complaints laboratory tested the quality control sample returned by the customer on different kits of vidas b.R.A.H.M.S pct on: - lot 1008527010 (retain kit and kit from customer).- lot 1008554150 (retain kit, lot used as reference).The results obtained were similar on both kits of lot 1008527010 and within acceptable ranges provided by bio-rad.Even if the result observed on lot 1008554150 was slightly higher than the one observed on lot 1008527010, the difference is not significant and is on line with the between-lot variability.Tests performed on quality control from thermofisher the complaints laboratory tested the quality control samples returned by the customer on different kits of vidas b.R.A.H.M.S pct: - lot 1008527010 (retain kit, lot mentioned by customers).- lot 1008554150 (retain kit, lot used as reference) the results obtained were similar on both kits and within acceptable ranges from customer.Even if the result observed on lot 1008554150 was slightly higher than the one observed on lot 1008527010, the difference is not significant and is on line with the between-lot variability.Even though the customer's out of range low issue was not reproduced internally, biomérieux initiated a meeting with bio-rad to be able to identify the root cause.3-4) actions with bio-rad a meeting was conducted with the biorad company to share the investigation outcomes.Biomérieux requested a meeting with the department in charge of value assignment at biorad; however, that department was not able to accommodate a meeting at this time.The other actions currently in process with the collaboration of bio-rad company will be implemented in the context of continuous improvement of complaints monitoring and management.4- conclusion: the investigation did not reproduce out of range low results when testing the quality control samples mentioned by the customers on vidas b.R.A.H.M.S pct lot 1008527010.All the results obtained complied with the expectations whatever the kit used (retain kit or customer¿s kit for the lot 1008527010 and retain kit for the reference lot 1008554150).All the conditions (quality control, samples and batch of vidas reagent) were tested.No root cause of the customer¿s issue was identified.There is no more of the samples available for testing; therefore, no further investigation can be pursued.However, the issue could have a multifactorial root cause including: - the sample handling (e.G reconstitution, homogenization, stability¿) - the calibration results - the instrument - statistical distribution and calculation.For a statistical point of view, it is possible time to time to have a data outside +/- 2 sd (wesgard rules and gaussian curve) and a minimum of 20 data are necessary to determine robust acceptable ranges.Collaboration with the bio-rad company will continue in the context of continuous improvement of complaints monitoring and management.There is no reconsideration of vidas b.R.A.H.M.S pct lot 1008527010.

• Brand Name: VIDAS BRAHMS PROCALCITONIN 60T
• Type of Device: VIDAS® BRAHMS PROCALCITONIN 60T
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 11772777
• MDR Text Key: 280884684
• Report Number: 8020790-2021-00119
• 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: 08/24/2021

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: 07/14/2022
• Device Catalogue Number: 30450
• Device Lot Number: 1008527010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 05/04/2021
• Supplement Dates Manufacturer Received: 07/26/2021
• Supplement Dates FDA Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1