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

Catalog Number 30450

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Event Description

Issue description: on (b)(6) 2022, customer from italy notified biomérieux of obtaining an false overestimated results when using vidas brahms procalcitonin 60t (ref.30450, batch number: 1009072010, expiry date: 09-may-2023) on patient samples.On (b)(6) 2022, one patient with arterial hypertension was tested in the emergency, he obtained the result as follow with a second other batch 1008979260: first test: sample vm22.03: 13.01 ng/ml.Second test: vm22.03: 12.92 ng/ml.On (b)(6) 2022, to compare this previous positive result with another batch, the physician obtained the following results with the batch 1009072010: vm22.03: 7.69 ng/ml.The infectious disease specialist excluded any type of respiratory disease as the other parameters were normal.The patient was retested in another lab with new sample and another method: abbot method: sample vm23.03: negative result the physician tested with a third another batch of vidas brahms procalcitonin: lot 1009154290: negative results.There is no indication or report from the laboratory that the issue led to any adverse event related to patient's state of health.A biomérieux internal investigation will be initiated.Note: reference 30450 is not sold or distributed in the united states.However, u.S-only product reference, 30450-01, has the same formulation and physical properties as reference 30450.

Manufacturer Narrative

An internal investigation was performed following a notification from a customer from italy that they obtained false positive results for one (1) patient sample (different blood collection ) using vidas brahms procalcitonin (ref.30450 lot 1008979260 and 1009072010).The false positive results were observed in comparison with competitor method (abbott) and other lot of brahms procalcitonin ref 30450, giving negative results.Investigation.Device history record.The review did not highlight any issue during manufacturing, control or packaging processes for vidas® brahms procalcitonin (ref.30450 lot 1008979260 and 1009072010).Complaint analysis.Complaint analysis did not reveal this issue to be a systemic quality problem.Quality control records.The analysis of control chart carried out on 4 internal samples (target 10.9 ng/ml ¿ 10.7 ng/ml ¿ 7.80 ng/ml and 0.08 ng/ml) and on 5 batches of vidas® brahms procalcitonin ref.30450 including the customer batches showed that all results are within specifications, customer¿s lots are in the trend of the other lots.*tests/analysis performed* all tests are performed on the retained kits vidas® brahms procalcitonin ref.30450.- 1008979260; - 1008999710; - 1009046630; - 1009072010; - 1009154290.There are the batches mentioned by customer and other batches with difference raw material.The patient¿s sample was sent by the customer.This sample was tested ¿pur¿, and overestimated results are reproduced with all batches excepted the batch 1009154290 (same issue as the customer).Sample was tested after treatment with hbt tube (search heterophilic interference) on batches 1008979260 ; 1009046630 and 1009072010: results are significantly lower highlighted potential cross reaction.The analysis of the raw material for the batches giving positive results, show the same lot of several raw material compare to the batch 1009154290.Root cause and conclusion.The results of investigation allow to identify a root cause.The false positive result observed by the customer is linked to non-specific binding between heterophilic antibodies in the patient samples and one component of the reagent vidas® brahms procalcitonin ref.30450.As mentioned in the ifu, limitations of the method: "interference may be encountered with certain samples containing antibodies directed against reagent components.For this reason, assay results should be interpreted taking into consideration the patient's clinical history, and the results of any other tests performed.When a high concentration of troponin is not compatible with the clinic signs and symptoms of the patient, the presence of an interfering factor in the sample should always be suspected.".According to the above data , vidas® brahms procalcitonin ref 30450 is within the expected performance.

• 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: candace martin ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 14212315
• MDR Text Key: 299295570
• Report Number: 8020790-2022-00050
• Device Sequence Number: 1
• Product Code: PRI
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2023
• Device Catalogue Number: 30450
• Device Lot Number: 1009072010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2022
• 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