MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS HCG 60 TESTS

Catalog Number 30405

Device Problem Low Test Results (2458)

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

Event Date 01/21/2021

Event Type  malfunction  

Event Description

Roduct 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 27-apr-2021, a customer from (b)(6) notified biomérieux that he obtained an out of range low result for an external quality control when using vidas hcg 60 tests (ref.30405, batch number 1008252950, expiry date 08-oct-2021).The expected result of qc sample instand ((b)(6) 2021, group 292) for hcg were as follows: sample 12: 4.94 iu/l [3.46 - 6.42] iu/l on (b)(6) 2021, the customer obtained for the same sample 12: 3.40 iu/l with the kit vidas hcg.To be noted that the customer used pipette under metrological control.The sample was already in suspension, kept at 2-8°c.The sample was tested on mini vidas analyzer.As this was a survey sample, there was no patient directly associated with the testing.Therefore, there was no adverse impact to any patient's state of health as a result of the testing.A biomérieux internal investigation will be initiated.Note: reference 30405 is not registered in the united states.The u.S similar device is product reference 30405-01 (k141133).

Manufacturer Narrative

A customer in germany notified biomérieux of obtaining out of range results (too low) on instand external quality control (eqc) samples n ° 12 group 292 when testing with vidas® hcg (ref.30405 lot 1008252950).Investigation.The customer no longer had any of the sample eqc available to submit for the investigation.Review of the batch history records did not reveal any anomalies during the manufacturing, control and packaging processes for vidas hcg, ref.30405 lot 1008252950.Control chart analysis.Biomérieux looked at four internal samples with a target within the measurement range of vidas hcg (target 2.18 / 2.97 / 4.29 /5.11 ui / l), on seven different batches of vidas hcg ref 30405 including lot 1008252950 mentioned by the customer.The analysis of the control charts showed that all results are within specifications, including the results from the customer¿s lot.Tests performed by complaint laboratory.Biomérieux complaint laboratory tested two samples from the activity panel, with a target within the measurement range of vidas hcg, on retain kit vidas hcg 1008252950.Both results were within specifications.The complaint laboratory participated in a french external quality control evaluation (probioqual) for vidas hcg test.All of the vidas peer group results were well-scored, with a good homogeneity between vidas attendees.Since the customer did not have any of their instand eqc sample available, the complaint laboratory tested this eqc probioqual sample on retain kit vidas hcg 1008252950.The eqc probioqual samples 20md04 and 20md10 result were both within expected ranges.Conclusion.According to all information above, there were no discrepancies nor non-conformances highlighted during the control chart analysis and the analysis of quality data for vidas hcg (ref 30405 lot 1008252950).In the absence of instand samples return, no further investigation can be pursued.For this sample, all manufacturers were evaluated together.The target value calculated in this way therefore differs from the mean values of the individual manufacturer collectives.The higher value obtained among all manufacturers is 43 ui/l for roche (cv for sample 12 : 74.7).The lower value is 3.40 for vidas (customer value).Eight of the study participants are vidas users.The mean for these eight users is 3.97 ui/l, so the determined range for the vidas peer group to 2sd range will be : [2.98-4.95].There is a significant inter- and intra-technique variability probably related to the nature of the sample itself.Additionally, quality controls are not identical to patient samples; qc manufacturing process can affect sample matrix and control results.It is mentioned in the clsi guideline ep14-a3 that processed samples used as qc material (eg eqa) can have matrix effect: ¿current scientific data suggest that such use of pt / eqa results is not always feasible because of matrix effects.These processed materials used as pt / eqa samples sometimes do not behave like patient samples routinely analyzed in the laboratory.Biases not generally seen with fresh biological fluids, are frequently seen with pt / eqa samples.¿.According to the information mentioned above, there is no reconsideration of the performance of vidas hcg, ref.30405 lot 1008252950.

• Brand Name: VIDAS HCG 60 TESTS
• Type of Device: VIDAS HCG 60 TESTS
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l'orme; marcy l¿etoile 69280 ; FR 69280
• MDR Report Key: 11876718
• MDR Text Key: 281408107
• Report Number: 8020790-2021-00125
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K141133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

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: 08/10/2021
• Device Catalogue Number: 30405
• Device Lot Number: 1008252950
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 07/05/2021
• Supplement Dates FDA Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1