MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® B¿R¿A¿H¿M¿S PCT¿; VIDAS BRAHMS PROCALCITONIN 60T

Catalog Number 30450

Device Problem Low Test Results (2458)

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

Event Type  malfunction  

Event Description

On (b)(6) 2022, a customer in france notified biomérieux of out of range low results when testing with vidas® brahms procalcitonin 60t (ref.30450, lot #1009009480, expiry date: 29-mar-2023) in context of external quality control (qc) sample on both iqc and eeq.Since changing to a new batch of vidas pct (new batch 1009009480), the customer has observed a drop in qc (in-house qc, patient pool - target at 1 ng/ml) to 0.74 - 0.77, 0.75 ng/ml.In addition, the customer had non-compliant probioqual eeq results: (b)(6) 2022: 22bg01: 4.28 ng/ml ( peer group target: 5.05 ng/ml).22bg02: 43.98 ng/ml (peer group target: 53.3 ng/ml).Retesting on the same batch, same calibration gave similar results: (b)(6) 2022: 22bg01: 4.03 ng/ml.22bg02: 40.93 ng/ml.To be noted, this eeq was tested internally and the results were compliant on another batch.Calibration data from 12feb2022 : (b)(6).Following a recalibration problem, the customer was asked to recalibrate after having vortexed the vials (new vial reconstituted from a new box).Calibration data from (b)(6) 2022: (b)(6).The customer then ran the qc and 2 levels of eeq.These values were now compliant.(b)(6).Vortexing the vials is mentioned in the package insert procedure; however, the customer had a valid calibration and the results were still lower than expected.There are no patients associated with these qc samples; therefore, there is no adverse event related to any patient's state of health.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

An internal investigation was performed following notification from a customer from france of obtaining out of range low results when testing with vidas® brahms procalcitonin 60t (ref.(b)(4), lot #1009009480, expiry date: 29-mar-2023) in context of external quality control (qc) sample on both iqc and eeq.Device history record; the analysis of the batch history record of vidas pct ref.30450 lot 1008722440 did not highlight any issue.Complaint analysis; the complaint analysis did not reveal this issue as a systemic quality issue.Control charts analysis; the complaint laboratory observed 4 internal samples, with 8 different lots of vidas brahms procalcitonin (including retained samples from the customer's lot 1009009480 ).- pa122 ranges 0.30 (0.20 ¿ 0.40) activity lot 1009009480 : 0.29 ng/ml; - pa123 ranges 0.34 (0.23 ¿ 0.45) activity lot 1009009480 : 0.32 ng/ml.- pa133 ranges 20.3 (15.9 ¿ 24.8) activity lot 1009009480 : 17.77 ng/ml.- pa137 ranges 32.2 (25.1 ¿ 39.4) activity lot 1009009480 : 31.89 ng/ml.The analysis of the control charts showed that all results are within specifications.Customer¿s lot is consistent with the other lots.Test/analysis performed.**customer¿s material** no customer¿s material was returned for investigation.** internal samples** four (4) internal samples were tested on the retain kits vidas brahms procalcitonin (pct)lot 1009009480 in order to check the conformity and the evolution of the batch since its release.Pa122 = 0.31 ng/ml.Target 0.30 [0.20 ¿ 0.40] ng/ml.Before release of batch : 0.29ng/ml.Pa123 = 0.31 ng/ml.Target : 0.34 [0.23 ¿ 0.45] ng/ml.Before release of batch : 0.32 ng/ml.Pa133 = 20.03 ng/ml.Target 20.3 [15.9 ¿ 24.8 ]ng/ml.Before release of batch : 17.77 ng/ml.Pa137 = 31.78 ng/ml.Target : 32.2 [25.1 ¿ 39.4 ] ng/ml.Before release of batch : 31.89 ng/ml.The results are all within the range of each samples.There is no significant drift of the batch since it release.**tests performed by complaint laboratory** without return customer¿s samples, the complaint laboratory tested 2 external samples from supplier probioqual 22bg01 et 22bg02 on retain kits of vidas brahms procalcitonin (pct) ref.(b)(4) lot 1009009480 and lot 1009233470 with other raw material range for vidas peer group.22bg01= [4,304- 5,824] ng/ml.22bg02= [45,575-61,661] ng/ml.Batch 1009009480.22bg01= 4,72 and 4,86 ng/ml.22bg02= 49,17 and 52 ng/ml.Batch 1009233470.22bg01= 5,70 ng/ml.22bg02= 56,12 ng/ml.All results are within their expected specifications.4.Root cause analysis and conclusion.The investigation did not reproduce the customer's issue when testing external samples probioqual 22bg01 et 22bg02 on vidas brahms procalcitonin (pct) ref (b)(4) lot 1009009480 and was unable to identify any obvious root cause.All the results are on expected ranges.According to the data mentioned above, there is no reconsideration of vidas brahms procalcitonin (pct) ref 30450 lot 1009009480.It is to be noted that the internal control result is linked to pre analytic and lot used.The pre-analytic steps : reconstitution of the lyophilized vials (diluent, volume, waiting time, mixing).The analytic steps : after reconstitution (mixing before the run).The important point also is to homogenize the internal control before test.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¿.

• Brand Name: VIDAS® B¿R¿A¿H¿M¿S PCT¿
• Type of Device: VIDAS BRAHMS PROCALCITONIN 60T
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l orme; marcy l etoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; 376 chemin de l orme; marcy l etoile 69280 ; FR 69280
• Manufacturer Contact: candace martin ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 13825684
• MDR Text Key: 297583092
• Report Number: 8020790-2022-00041
• Device Sequence Number: 1
• Product Code: PRI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2023
• Device Catalogue Number: 30450
• Device Lot Number: 1009009480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1