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

Model Number 30450-01

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 in the united states notified biomérieux of obtaining non-reproducible results when performing a correlation study with vidas® brahms procalcitonin 60t (ref.30450-01, lot 1008647850, expiry 14-sep-2022).The customer was performing a correlation study between their vidas 3 instrument and beckman coulter instrument.The customer ran 20 samples on their vidas 3, and then samples were aliquoted and sent to their sister lab to test on beckman colter.(b)(6).The calibration was valid and the c1= 18.90 and c2=1.89 controls were within the expected ranges.S1 rfv range 1909-3410, s1 rfv 2885, s2 rfv range 321-573, s1 rfv 493.C1 range 14.33-22.39, c2 range 1.37-2.21 ng/ml.The customer tested patient samples on vidas 3 (in sst tube, waiting 30 min after collection, then centrifugation 1300-200 g during 10 min at 20-25°c).After transferring the sample to another tube (samples separated from the clot can be stored at 2-8°c in stoppered tubes for up to 48 hours), they were sent to an external site for testing on beckman.The customer was informed that the correlation should be performed on a minividas, vidas, or vidas 3 to be a like for like correlation that has same methodology.The customer was able to correlate to a third instrument and found the correlations passed.The type of instrument was no specified.There is no indication or report from the laboratory that the discrepant results led to any 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 notification from a customer in the united states of obtaining non-reproducible results when performing a correlation study with vidas® brahms procalcitonin 60t (ref.30450-01, lot 1008647850, expiry 14-sep-2022).Investigation.A device history record review did not highlight any issue during manufacturing for vidas brahms procalcitonin (ref 30450-01; batch 1008647850).There are no capas, nor non-conformities on vidas brahms procalcitonin (ref 30450-01 batch 1008647850) linked with customer 's complaint.The analysis of control charts conducted on 5 internal samples (target: 0.30 ng / ml; 3.03 ng / ml; 0.87 ng / ml; 1.22 ng / ml; 32.2 ng / ml) for 7 batches of vidas brahms procalcitonin including the customer batch 1008647850 showed that all results are within specifications.Customer's lot is consistent with the other batches.Next, analyses were done on retained kit vidas brahms pct ref 30450-01 batch 1008647850, using 4 internal samples (target 3.03 ng / ml; 0.30 ng / ml ; 1.22 ng / ml and 32.24 ng / ml).The results obtained on the samples did not exhibit any result drift for lot# 1008647850 since its release; the results obtained on the pv kit being similar to those obtained during the activity control.The investigation laboratory participates in the campaign of external quality assessment of the suppliers probioqual (fr) and cap survey (us) for the procalcitonin parameter.For the probioqual campaign: 14 samples were analyzed with concentration between 0.458 - 45,314 ng / ml for vidas and 0.462-52,661 ng / ml for beckman.The precision cv for the peer group of both method is <10%.For low concentration (<10 ng / ml) the difference between both method never exceed 10%.For concentration> 10 ng / ml the difference between both methods can go up to 20 %.For cap survey campaign : 5 samples analyzed with concentration between 0.427 -7.647ng/ml for vidas and between 0.603¿ 9.819 ng/ml for beckman.The precision cv for the peer group of both method is <10% the difference between both methods can go up to 30%.An publication, "analytical performance of the vidas® brahms procalcitonin assay and beckman coulter unicel® dxi procalcitonin assay in a stat laboratory," concluded that a high correlation exists between quantitative procalcitonin measurements conducted with the vidas® brahms and the beckman coulter unicel® dxi assays.The package insert states that, as no international standard is available, vidas® b · r · a · h · m · s pct ¿ (pct) is calibrated against an internal panel of human sera with known procalcitonin concentrations consistent with other b · r a h m s pct assays.It is recommended that facilities use the same pct assay technique when follow up patient testing is needed.Conclusion.The investigation did not identify any obvious root cause of the customer's reported issue.According to all data above, there is no reconsideration of the performance of vidas brahms procalcitonin ref.30450-01 batch 1008647850.

• 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, rhone 69280 ; FR 69280
• MDR Report Key: 12436730
• MDR Text Key: 283319522
• Report Number: 8020790-2021-00181
• Device Sequence Number: 1
• Product Code: PRI
• UDI-Device Identifier: 03573026223601
• UDI-Public: 03573026223601
• Combination Product (y/n): N
• PMA/PMN Number: K162827
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

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: 09/14/2022
• Device Model Number: 30450-01
• Device Catalogue Number: 30450-01
• Device Lot Number: 1008647850
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1