MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® BRAHMS PROCALCITONIN

Model Number 30450-01

Device Problem Low Test Results (2458)

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

Event Date 09/01/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, a customer from the united states notified biomérieux of obtaining underestimated results when testing external quality control with vidas brahms procalcitonin 60t (ref.30450-01, batch number: 1009182760, expiry date: 05-jul-2023).The customer participated to the linearity/ calibration k841m-5 lot 06790 from audit.The customer tested the different external quality control on (b)(6) 2022 and obtained underestimated result for levels b, c, d and e compared to peers, as follows: level b: peer mean = 44.006 ng/l (n=12) ¿ user mean = 38.8 ng/l.Level c: peer mean = 92.705 ng/l (n=12) ¿ user mean =77.36 ng/l.Level d: peer mean = 151.022 ng/l (n=12) ¿ user mean = 122.8 ng/l.Level e: peer mean = 187.518 ng/l (n=8) ¿ user mean = 144.84 ng/l.To be noted that the calibration of the kit vidas brahms procalcitonin 60t (ref.30450-01, batch number: 1009182760) was performed on the (b)(6) 2022 and was valid.As there is no patient associated with this external quality control, there is no adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal investigation was performed following a notification from a customer in the united states who obtained underestimated results when testing external quality control from linearity & calibration verification (audit micro control, lot 06790) with vidas brahms procalcitonin 60t (ref.30450-01, batch number: 1009182760, expiry date: 05-jul-2023).1) complaint analysis at the date of investigation, no others complaints were recorded for underestimated result with vidas b.R.A.H.M.S pct ref.30450-01, lot 1009182760.2) quality control records there is neither capa nor non-conformity linked to this issue on this vidas assay.3) analysis and tests conducted by complaints laboratory a) control chart analysis this analysis was carried out: - on four (4) internal samples with a respective target at 0.12 / 32.2 / 91.1 and 159 ng/ml.- on seven (7) batches of vidas b.R.A.H.M.S pct ref.30450-01 including the customer¿s lot (1009182760).The analysis of the control charts showed that all results are within specifications and the lot mentioned by the customer is in the trend compared to the other lots.B) tests performed using samples from amc kit lot 06790 the complaints laboratory tested the different vials (a to e) from a kit of linearity & calibration verification (same lot as customer 06790) in duplicate on retain kit vidas b.R.A.H.M.S pct ref.30450-01 lot 1009182760.All the vials gave results higher than the ones from the vidas peer group with results within +2sd for vials b to e and a result just above + 2 sd for vial a ( 0.105 ng/ml for user mean at 0.086 ng/ml).The linearity was good with a r-square at 0.997 and slope at 1.015 (so both close to 1).A repetition testing was done on new vials of c, d and e.Unfortunately, it was not possible for vials a and b because of a volume issue during the reconstitution of the 1st set of vials a and b so the vials were discarded and 2nd set of vials was used during the 1st testing.Analysis was done using initial results for samples a and b and new results for samples c to e.All the vials gave results higher than the ones from the vidas peer group with results within +1sd for vials b to e.The linearity was good with a (b)(4) (both close to 1).For both testing, the linearity was conform and the issue (underestimated results) reported by the customer was not reproduced.However, the y intercept was not totally optimized.C) tests performed using internal samples the complaints laboratory conducted a linearity study using internal samples.Two internal samples were selected, one with a low concentration (0.15 ng/l) and the second one with high concentration (230 ng/ml).Dilutions were carried out using the same dilution process as amc (see below) sample a= no dilution => low concentration sample e= no dilution => high concentration sample b= sample a diluted 3:4 + sample e diluted 1:4 => middle low concentration sample c= sample a diluted 1:2 + sample e diluted 1:2 => middle concentration sample d= sample a diluted 1:4 + sample e diluted 3:4 => middle high concentration the samples a to e were tested in duplicate on retain kit vidas b.R.A.H.M.S pct ref.30450-01 lot 1009182760.The results obtained complied with expectations with results between 0.15 ng/ml (sample a) and 227.5 ng/ml (sample e).The other points gave linear results, well distributed along the curve leading to a r-square at 0.997, a y-intercept at 0 so conform.A comparison of results was done between the results obtained and the theoretical ones for assessment of the accuracy.The bias calculated for all the samples was far from 10% and it was a positive bias for samples a, b, c and d, a very low negative bias was observed for sample e (about -1%).So the recovering factor is excellent using these natural samples.Conclusion **************** the customer issue, underestimated result, was not reproduced when conducting a linearity study using samples from a kit of linearity & calibration verification (same lot as customer 06790) and internal samples.However, better results were obtained when using the internal samples than the ones using a kit from amc.The difference could be linked to the manufacturing process and raw material, especially the recombinant procalcitonin protein, used by audit micro control; this is known as matrix effect.The results observed using natural samples complied to expectations.The phenomena observed by the customer can be due to one or a combination of causes listed below: - the quality control sample processed by the customer (e.G reconstitution, stability, homogenization, and handling).- the calibration results.- the matrix of the sample - instrument for reminder, it is mentioned in the clsi guideline ep14-a3 that processed samples used as qc material (e.G eqa) can have matrix effect.¿current scientific data suggest that such use of pt/ eqa results is not always feasible because of matrix effects.These processed materials us as pt/ eqa samples sometimes do not behave like patient samples routinely analyzed in the laboratory.Biases not generally seen with fresh biological fluids, are frequently seen with pt / eqa samples¿.According to the investigation outcomes, there is no reconsideration of vidas b.R.A.H.M.S pct ref.30450-01, lot 1009182760.

• Brand Name: VIDAS® BRAHMS PROCALCITONIN
• Type of Device: VIDAS® BRAHMS PROCALCITONIN
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMÉRIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer Contact: sandra locca-bernard ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 15503046
• MDR Text Key: 303758703
• Report Number: 8020790-2022-00097
• Device Sequence Number: 1
• Product Code: PRI
• UDI-Device Identifier: 03573026223601
• UDI-Public: 03573026223601
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162827
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2023
• Device Model Number: 30450-01
• Device Catalogue Number: 30450-01
• Device Lot Number: 1009182760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1