MAUDE Adverse Event Report: BIOMÉRIEUX SA VIDAS® PROGESTERONE

Catalog Number 30409

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Event Description

Product description: vidas® progesterone is an automated quantitative test for use on the vidas® family instruments for the quantitative measurement of progesterone in human serum or plasma (lithium heparin or edta), using the elfa technique (enzyme linked fluorescent assay).Issue description: on (b)(6)2022, a customer from india notified biomérieux of potential over-estimated patient results when using vidas® progesterone reference(b)(4) lot 1009453360 (expiry 25-may-2023).The customer sent three (3) progesterone samples to an outside lab to re-test (clia method) to confirm suspected over-estimated results using the the vidas® progesterone reference (b)(4) lot 1009453360 kit.Test results listed below: 1st sample: vidas progesterone result : 2.06 ng/ml outside lab result: 0.14 ng/ml.2nd sample: vidas progesterone result: 1.91 ng/ml outside lab result: 0.069 ng/ml.3rd sample: vidas progesterone result: 1.25 ng/ml outside lab result: 0.14 ng/ml.Vidas: standard rfv , control values and background values was acceptable.The calibration/control was re-run and was valid.No physical issues were found in the kit.At the time of this assessment, no patient harm or incorrect treatment was reported.Note: the product, vidas® progesterone (30409), is not marketed, sold or distributed in the united states.However, a similar product, vidas® progesterone (30409-01) is marketed in the united states.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

An internal investigation was performed following notification from a customer in india of potential over-estimated patient results when using vidas® progesterone reference (b)(4) lot 1009453360 (expiry 25-may-2023).Investigation: device history record: the review did not highlight any issue during manufacturing for vidas prg reference (b)(4); batch 1009453360.There was no capa or non conformity on vidas prg reference (b)(4); batch 1009453360 linked with the customer complaint.Complaint analysis: the analysis of complaints did not reveal a systemic quality issue.Control chart analysis: the analysis of control chart carried out on four (4) internal sample (target 0.31 ng/ml, 0.67 ng/ml, 0.30 ng/ml, 0.47 ng/ml ) and seven (7) batches of vidas prg reference (b)(4) including the batch used by the customer.The batch vidas prg reference (b)(4); batch 1009453360 is in the trend of other batches.All the samples studied are within the expected ranges.Tests/analysis performed: customer samples were not available for investigation.Further investigation was completed using internal samples.Investigation protocol and obtained results: analyses were done on retained kit vidas prg reference (b)(4); batch 1009453360 and one other batch 1009591390 manufactured with other raw material.Three (3) internal samples were tested on the kits vidas prg reference (b)(4); batches 1009453360 and 1009591390.All sample results were within expected ranges.There is no drift of the batches since its release.Additionally, four (4) samples reports from the last campaign of probioqual (eqc) were analyzed between vidas, roche, and abbott methods.This analysis shows a slight difference between the methods, however the difference observed between the three (3) techniques does not reflect the difference observed by the customer.Root cause analysis and conclusion: the investigation did not manage to identify any obvious root cause.Several potential root causes were ruled out.Some hypotheses were identified, without any possible verification as a real root cause.As mentioned in the ifu, interference may be encountered with certain sera containing antibodies directed against reagent components.For this reason, assay results should be interpreted taking into consideration the patient¿s history and the results of any other tests performed.In cases of steroid therapy, particularly micronized progesterone therapy, overestimated results may sometimes be obtained.Moreover the interpretation of test results should be made taking into consideration the patient's history, and the results of any other tests performed.There is no reconsideration of the performance of vidas prg ref (b)(4); batch 1009453360 to its expectations.

• Brand Name: VIDAS® PROGESTERONE
• Type of Device: VIDAS® PROGESTERONE
• Manufacturer (Section D): BIOMÉRIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMÉRIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer Contact: matt floretta ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 16151577
• MDR Text Key: 308868207
• Report Number: 8020790-2023-00002
• Device Sequence Number: 1
• Product Code: JLS
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K965084
• 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: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2023
• Device Catalogue Number: 30409
• Device Lot Number: 1009453360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1