MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® B·R·A·H·M·S PCT ¿

Catalog Number 30450

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Event Description

On (b)(6)2023, a customer from french polynesia notified biomérieux of obtaining potential overestimated results when using vidas® brahms procalcitonin 60t (ref.30450, batch number: 1009747190, expiry date: 08-may-2024) with patient samples.The customer performed testing on patient samples, and he obtained the following result: patient 2: 21,05 ng/ml.Potential overestimated results are suspected because the customer stated that results were not in accordance with the clinical context of the patient.Results were sent to the physician and at the time of this assessment, there is no indication or report from the laboratory that the issue led to any adverse event related to patient's state of health or delayed result.A biomérieux internal investigation will be initiated.Note: reference(b)(4) is not registered in the united states.The u.S.Similar device is product reference (b)(4).

Manufacturer Narrative

An internal investigation was performed following a notification from a customer in france (french polynesia) that he suspected false positive results when testing 2 patients¿ samples with vidas® brahms procalcitonin 60t (ref.(b)(4)).Some information was made available after initial reporting of this incident: - the impacted batch reference: (b)(4), expiry date 28-may-2024; - the clinical information about the patient 1: renal disorder (no more details) as underlying condition; - a second result for patient 2: 20.87 ng/ml.** investigation results ** 1) device history record the review did not highlight any issue during manufacturing for vidas® brahms procalcitonin 60t (ref.(b)(4), lot 1009747190, expiry date 28-may-2024).2) complaint analysis at the date of investigation, no other complaints were recorded for false positive results on vidas® b.R.A.H.M.S pct ref.(b)(4) lot 1009747190.3) tests/analysis performed by complaints laboratory *products return* no patients sample was available for testing purpose.*control chart analysis* this analysis was carried out: - on four (4) internal samples with a respective target at 0.12 ¿ 0.34 ¿ 1.22 and 30.7 ng/ml.- on seven (7) batches of vidas b.R.A.H.M.S pct ref.(b)(4) including the lot 1009747190 mentioned by the customer.The analysis of the control charts showed that all results were within specifications and the lot 1009747190 was in the trend compared to the other lots.*test on internal samples* the complaints laboratory tested: - four (4) internal samples with a respective target at 0.08 ¿ 0.34 ¿ 1.22 and 7.80 ng/ml using vidas b.R.A.H.M.S pct lot 1009747190 the results complied with the specification of vidas® brahms procalcitonin 60t ref.(b)(4)and they were not significantly different compared to those observed before the batch release.No evolution over time of these samples activity was observed.*analysis of report from external quality assessment organization* the complaints laboratory subscribed to a french external quality assessment organization including a program related to the blood procalcitonin testing.The complaints laboratory tested the quality control samples from different challenges as an ordinary laboratory (blind test).The results obtained on 6 samples with concentrations between 0.586 and 16.594 ng/ml were consistent with expectations and the french organization noticed in the report that all the methods, including vidas, gave satisfactory performances.** conclusion of the investigation ** the complaints laboratory did not reproduce the issue reported by the customer (result too high) when testing internal samples on vidas® b.R.A.H.M.S pct lot 1009747190.Without any patients¿ sample available and relevant information regarding either the clinical status (that could explain falsely high levels of pct in the absence of a bacterial infection) or results obtained using a competitor method, it is not possible to pursue further the investigation and explain the positive results observed by the customer.According to the data mentioned above, there is no reconsideration of the performance of vidas® b.R.A.H.M.S pct lot 1009747190.

• Brand Name: VIDAS® B·R·A·H·M·S PCT ¿
• Type of Device: VIDAS® B·R·A·H·M·S 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'étoile 69280 ; FR 69280
• Manufacturer Contact: ines el oueryemmi ; 5 rue des acqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 16861055
• MDR Text Key: 314578466
• Report Number: 8020790-2023-00031
• Device Sequence Number: 1
• Product Code: PRI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K160911
• 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: 06/27/2023

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: 05/08/2024
• Device Catalogue Number: 30450
• Device Lot Number: 1009747190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/03/2023
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 06/27/2023
• 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