MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® BRAHMS PCT¿

Catalog Number 30450

Device Problem False Positive Result (1227)

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

Event Type  Injury  

Event Description

On 09-nov-2023, a customer from france notified biomérieux of obtaining a potential false positive result when testing a patient sample with vidas brahms procalcitonin 60t (ref.30450, lot number: 1010128530, expiry date: 17-dec-2024).The patient is a 16-year-old girl admitted to the emergency department for voluntary drug intoxication and abdominal pain.The patient said that she took paracetamol and 4 amoxicillin 1g tablets.At her admission, biological workup was normal (crp 1, no infectious signs, no fever).The hepatotoxicity was also monitored: hepatic enzyme and bilirubin were normal.No cytolysis observed.The paracetamolemia was < 5 g/ml.Amoxicillin in the blood was not measured.On 07-nov-2023, the customer also analyzed a patient sample with vidas brahms procalcitonin 60t (ref.30450, lot number: 1010074360) and the result was: 44.07 ng/l based on this result, the patient was hospitalized for observation, no drug treatment given during hospitalization.On 09-nov-2023, a new sample was tested with vidas brahms procalcitonin 60t (ref.30450, lot number: 1010128530) and the result was: 5.06 ng/ml.The sample collected on 07-nov-2023 kept in a refrigerated storage was retested with vidas brahms procalcitonin 60t (ref.30450, lot number: 1010128530) and the result was: 32.44 ng/ml to be noted that the calibration of the kits vidas brahms procalcitonin 60t (ref.30450, lot number: 1010074360 and 1010128530) were valid.According to the customer's comments, the reason for performing a pct test on the patient could not be confirmed by the physician.The issue described with the kit vidas brahms procalcitonin 60t (ref.30450, lot number: 1010074360) was assessed separately (b)(6).Note: reference 30450 is not sold or distributed in the united states.However, a similar device us-only product reference 30450-01, is sold in the united states.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

An internal investigation was performed following a notification from a customer from france who obtained a potential false positive result when testing a patient sample with vidas® brahms procalcitonin 60t, ref.30450, lot 1010074360 (reported in mdr# 8020790-2023-00048) and lot 1010128530 (reported in mdr# 8020790-2023-00049).1.Device history record.There was no anomaly during the manufacturing, control and packaging processes recorded on vidas brahms procalcitonin 60t (ref.30450) with the two (2) lots 1010074360 and 1010128530.2.Complaint analysis the complaint analysis did not reveal this issue as a systemic quality issue.3.Tests/analysis performed.3.1) study of internal samples control charts: the complaints laboratory analyzed four (4) internal samples on seven (7) batches of vidas brahms procalcitonin 60t (ref.30450) including the lots mentioned by the customer with the following targets: 0.08 ng/ml ; 0.34 ng/ml ; 30.7 ng/ml and 40.9 ng/ml.The analysis of the control charts showed that all results were within specifications.The lot 1010074360 and lot 1010128530 are in the trend of the other lots.3.2) test on internal samples.The complaints laboratory tested three (3) internal samples with targets on the retain kit vidas brahms procalcitonin 60t (ref.30450) lot 1010074360 and lot 1010128530 (lots mentioned by the customer) with targets: 0.08 ng/ml ; 0.34 ng/ml and 40.9 ng/ml.Results obtained are within the acceptable ranges and similar to those observed before the batches release.We do not observe any evolution over time of the batch.3.3) test on return sample.The customer returned patient samples: - tube 1: gel tube, serum pct 44 ng/ml (> 500 l).- tube 2: heparin plasma pct 5 ng/ml (< 500 l).3.3.1) measurement of sample: the complaints laboratory tested the two (2) customer samples and a reference sample (target = 40.9 ng/ml) on the retain kit of vidas brahms procalcitonin 60t (ref.30450) lot 1010074360 (lot mentioned by the customer).Results obtained were as follows: - reference sample: 38.44 ng/ml; - tube 1 (serum): 31.75 ng/ml; - tube 2 (heparin plasma): 4.73 ng/ml.The results obtained by the customer was reproduced internally.3.3.2) interference search.In case of false result, it¿s necessary to search if interferences can explain such behavior.For that a ¼ dilution has been performed with some free serum according to the ifu with the retain kit of vidas brahms procalcitonin 60t ref.30450, lot 1010074360 (lot mentioned by the customer).Results obtained taking into account the dilution factor were as follows: - reference sample: 34 ng/ml; - tube 1 (serum): 26.8 ng/ml; - tube 2 (heparin plasma): 3.88 ng/ml.These results are similar to the results obtained when sample is pure.The dilution test did not find evidence of the presence of an interference.3.3.3) measurement of sample with a competitive method: cmia - alinity b.R.A.H.M.S pct from abbott.Due to an insufficient volume of the tube 2, only the tube 1 could be outsourced at biomnis laboratory, and it gave a result = 17.76 g/l (= 17.76 ng/ml).According to alinity b.R.A.H.M.S pct package insert, for any concentration > 2 ¿g/l there is a risk of progression to a severe sepsis or a septic shock.The result obtained with cmia - alinity b.R.A.H.M.S pct from abbott confirms the result obtained with vidas technique; the clinical interpretation remains the same for both methods with a 2 ng/ml cut-off.4.Root cause analysis and conclusion.According to the investigation outcomes, no anomaly was highlighted with the control chart analysis or the test performed on internal samples with the kit vidas brahms procalcitonin 60t (ref.30450) lots 1010074360 and lot 1010128530.Moreover, there is no recurrence of the customer's issue on these batches.No interference was identified on vidas based on the dilution test.Nevertheless, it doesn¿t mean there is no interference.The results obtained between vidas and alignity analysers are similar (false positive result on the first blood sampling from the 16 years old patient).A non-specific reaction (medication interference?) occurred for both techniques (using brahms pct license) leading to have a false positive result.According to all data, there is no reconsideration of the performance of vidas brahms procalcitonin 60t (ref.30450) lot 1010074360 and lot 1010128530.

• Brand Name: VIDAS® BRAHMS PCT¿
• Type of Device: VIDAS® BRAHMS PCT¿
• 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: sandra locca-bernard ; 5 rue des acqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 18276065
• MDR Text Key: 329848741
• Report Number: 8020790-2023-00049
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 30450
• Device Lot Number: 1010128530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization