MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® HCG

Catalog Number 30405

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Event Description

Product description: vidas® hcg is an automated quantitative test for use on the vidas® family instruments, for the quantitative measurement of human chorionic gonadotropin in human serum or plasma (lithium heparin or edta) using the elfa technique (enzyme linked fluorescent assay).Issue description: on (b)(6) 2023, a customer from canada notified biomérieux of obtaining overestimated result when testing external quality control with vidas hcg 60 tests (ref.30405, batch number: 1009680630, expiry date: 03-oct-2023).The external quality control used by the customer is the level 1 (lot: 85301) from bio-rad liquichek immunoassay plus control (lot: 85300).The expected ranges according to bio-rad for level 1 is: 5.33 (3.34 ¿ 7.32) miu/ml.The customer obtained 2 values for level 1 that were out-of-range: 8.04 and 9.49 miu/ml.Due to this out of range result for qc sample, the patients' samples were sent to another laboratory, which delayed the results by two days.The number of concerned patients was not specified.Based on the available information at the time of this assessment, there is no indication or report from the laboratory that the delayed result led to any adverse event related to patient's state of health.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 from canada who obtained overestimated result when testing external quality control with vidas hcg 60 tests (ref.(b)(4), batch number: 1009680630, expiry date: 03-oct-2023).1.Device history record the review did not highlight any issue during manufacturing for vidas hcg ref.(b)(4) lot 1009680630.2.Complaint analysis at the date of investigation, no others complaints were recorded for overestimated result on vidas hcg ref.(b)(4) lot.1009680630.3.Tests/analysis performed 3.1.Study of internal samples control charts: this analysis was carried out : - on 4 internal sera vidas hcg with targets between 4.29 to 156 mui/ml.- on 7 batches of vidas hcg including the batch mentioned by the customer all values are within their specifications, customer¿s lot is in the trend of the other lots.3.2.Study on internal samples: the complaints laboratory tested 3 internal samples with following targets (1.96-6.90), (1.84-6.74) and (2.51-7.71) on the retain kit vidas hcg ref (b)(4) lot 1009680630 (lot mentioned by the customer).Sample results are within their expected specifications.4.Root cause analysis and conclusion according to all information above, no anomaly was highlighted during the control chart analysis and the analysis of quality data for number vidas hcg ref.(b)(4) lot 1009680630.In the absence bio-rad qc samples, it is impossible to pursue further investigations.This quality control lot is no longer available for sale.The most likely hypothesis would be due for one or more of the causes listed below: - the quality control sample processed by the customer (e.G stability, homogenization, handling¿).- the instrument (respect of instructions of use related to preventive maintenance and monitoring with weekly qcv testing).- the calibration results.According to the investigation outcomes, there is no reconsideration of vidas hcg ref.(b)(4) lot 1009680630.

• Brand Name: VIDAS® HCG
• Type of Device: VIDAS® HCG
• 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 aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 16752106
• MDR Text Key: 313842023
• Report Number: 8020790-2023-00028
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K141133
• 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: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2023
• Device Catalogue Number: 30405
• Device Lot Number: 1009680630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1