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 Patient Involvement (2645)

Event Type  malfunction  

Event Description

On (b)(6) 2020 a customer in (b)(6) reported to biomérieux that they observed under-estimated results when using vidas® pct (ref 30450, lot 1008130900, expiry date 06 dec 2021) in a context of external quality control (thermofisher).The customer used two levels; the technical information related to these iqc are reported as follows: - level n1 supplier target: 0.29 / supplier ranges: 0.23-0.365 / customer target: 0.22 (low) - level n2 supplier target: 2.40 / supplier ranges: 1.95-2.930 / customer target : 2.73 (acceptable) the results of the last calibration, performed (b)(6) 2020, of vidas pct (lot 1008130900) are reported below: s1 2740/2752 rfv , range: 2034-3632 rfv (acceptable) - s2 523/523 rfv , range: 338-604 rfv (acceptable) - c1 827 rfv 17.11ng / ml , titer range: 12.96-20.24ng / ml (acceptable) - c2 218 rfv 1.72ng / ml , titer range:1.34-2.16ng / ml (low) the customer obtained the following results for the two levels of iqc: for level n1, result at 0.20; outside supplier ranges (low) - for level n2, results at 1.94 / 1.89 / 1.93; outside supplier ranges (low) the customer performed a new calibration on (b)(6) -2020: s1 2478/2415 rfv , rfv range : 2034-3632 rfv (acceptable) - s2 460/466 rfv , rfv range : 338-604 rfv (acceptable) - c1 758 rfv 17.53ng / ml , titer range : 12.96-20.24ng / ml (acceptable) - c2 201 rfv 1.79ng / ml, titer range : 1.34-2.16ng / ml (acceptable) the customer obtained 0.24 (acceptable) for level n1 and 2.17 (acceptable) for level n2 global analysis of the data obtained by the customer was performed by the biomérieux global customer service (gcs) and showed the following results: - for level n1, cumulative mean = 0.26 ng/ml range (2sd) = 0.19 ¿ 0.33 ng/ml cv = 13.1%.One result was out of range low = 0.18 ng/ml.Mobile mean = 0.28 ng/ml range (2sd) = 0.22 ¿ 0.33 ng/ml cv = 9.6%.Nine results were out of range [manufacturer mean = 0.29 ng/ml range = 0.23 ¿ 0.365] - for level n2, : mean = 2.463 ng/ml range (2sd) = 2.11 ng/ml ¿ 2.81 ng/ml (cv = 7.1%) as there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.The customer reported that they did not observe this issue with patient samples.

Manufacturer Narrative

This report was initially submitted following notification from a customer in france regarding observed under-estimated results when using vidas® pct (ref (b)(4), lot 1008130900, expiry date 06 dec 2021) in a context of external quality control (thermofisher).The results obtained were not compliant to the customer's acceptable requirements based on the target +/- 2sd.Note: the storage conditions, at the complaint laboratory reception, were not in accordance with the thermofisher's recommendation and therefore a potential impact on the results related to the stability of the quality control cannot be excluded.Control card analysis performed on four (4) internal samples and seven (7) lots including the customer's lot , shows the vidas® pct lot 1008130900/211206-0 (retain kit) is in the trend of the other lots.All of the results were within specifications.The complaints laboratory tested two (2) samples returned by the customer as well as four (4) samples from the activity panel, and six (6) eeq cap survey from the campaign.The results complied with the standards of each internal sample and their standards.There was no drift in vidas® pct lot 1008130900 (retain kit) since release.Samples and the vidas® kit returned by the customer have been tested.The results comply with supplier standards but are within the low standards, or even below the standard established by the customer.The lower results observed with the return kit could be explained by the combination of several factors of the matrix variability and the stability of the quality control.Clsi guideline ep14-a3 states 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¿.The customer's anomaly was not reproduced on the vidas® pct lot 1008130900/211206-0 with the internal samples, the eeq thermofisher returned by the customer, or the eeq cap survey.No product malfunction has been identified for vidas® pct lot 1008130900.The analysis of the batch history records showed no anomalies during the manufacturing, quality control, and packaging processes.There have been no other complaints on this batch for this issue.See section h10.

• 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: 10623162
• MDR Text Key: 230182192
• Report Number: 8020790-2020-00095
• 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: 12/10/2020

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: 09/03/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1