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 27-dec-2022, a customer in india notified biomérieux that they observed overestimated results when testing three patient samples using vidas progesterone 60 tests (ref.30409, batch number 1009453360, expiry date 25-may-2023) compared to other methods.It is reported that the customer sent the patient samples, each to a different local reference laboratory and all results were the same, meaning lower than the results obtained with vidas progesterone 60 tests.Results obtained with vidas progesterone 60 tests (ref.30409) lot 1009453360: sample 1, result on 25-dec-2022 at 10:52 am (section b1): 4.05 ng/ml.Sample 2, result on 25-dec-2022 at 12:02 pm (section d1): 3.20 ng/ml.Sample 3, result on 28-dec-2022 at 12:50 pm (section b1): 2.97 ng/ml.These results were preceded by a valid calibration performed on 23-dec-2022.The customer stated that they did not release the patients¿ results because they were not correlated to their clinical status.At the time of this assessment, the patients¿ clinical context was not known.Results obtained with the other reference laboratories: result obtained on 25-dec-2022 at 04:51 pm with chemiluminescence method (cmia): < 0.1 ng/ml.Result obtained on an unkown date with an unknown method: 0.2 ng/ml.Result obtained on 28-dec-2022 for a 35 year-old woman with cobas method by roche: 0.31 ng/ml (indicating follicular phase).At the time of this assessment, the correspondence between each result and the samples tested with vidas was unclear.There is no indication or report from the customer that the issue led to any adverse event related to any patient's state of health.A biomérieux internal investigation was initiated.Note: reference 30409 is not sold or distributed in the united states.However, there is a similar device, u.S-only product reference, (b)(4).

Manufacturer Narrative

An internal investigation was opened following a notification from a customer in india that they observed overestimated results when testing three patient samples using vidas progesterone 60 tests (ref.30409, batch number: 1009453360, expiry date 25-may-2023) compared to a competitor method (clia).Investigation results: 1.Device history record.The review did not highlight any issue during manufacturing for vidas progesterone 60 tests (ref.30409), batch number: 1009453360.2.Complaint analysis: the complaint analysis did not reveal this issue as a systemic quality issue.3.Control chart analysis: the analysis of control charts carried out on 4 internal samples (targets 0.31 ng/ml; 0.67 ng/ml ; 0.30 ng/ml and 0.47 ng/ml ) using 7 lots of vidas progesterone 60 tests (ref.30409) including customer's lot: 1009453360 showed that lot: 1009453360 is in the trend of other lots and that all tested samples are within their expected ranges.4.Tests/analysis performed.No sample was returned by the customer.Analyses were performed on the retained kit of vidas progesterone 60 tests (ref.30409) lot: 1009453360 and on another lot: 1009591390 manufactured with other raw materials.3 internal samples were tested on the kits vidas prg ref: 30409, batches: 1009453360/230525-0 and 1009591390.All samples were compliant to their norms.There was no drift of the lots since their release.Moreover, 4 samples' reports from the last campaign of probioqual (external quality check) were analyzed with vidas, roche and abbott methods: this analysis showed a slight difference between these methods but the observed difference does not reflect the difference observed by the customer.5.Root cause analysis and conclusion.The investigation did not manage to identify any obvious root cause of customer's issue but allowed to rule out several potential root causes.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.In view of all these elements, there is no reconsideration of the performance of vidas progesterone 60 tests (ref.30409) lot: 1009453360.

• 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 Contact: dima amro ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 16210186
• MDR Text Key: 308645994
• Report Number: 8020790-2023-00005
• 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: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• 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