MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® PROGESTERONE 60 TESTS

Catalog Number 30409

Device Problem Low Test Results (2458)

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

Event Type  malfunction  

Event Description

On (b)(6) 2022, a customer in colombia notified biomérieux of underestimated results when testing with vidas® progesterone 60 tests (ref.30409, lot #1009453360, expiry date: 25-may-2023) in context of external quality control (randox immunoassay).The customer performed calibration of this kit (1009453360) and all values were within range.The calibration was valid.On (b)(6), third opinion controls were processed: immunoassay premium plus - level 1 (imm1), level 2 (imm2), and level 3 (imm3): imm1: * value obtained: 1.14 ng/ml * expected range: 1.1 - 1.64 ng/ml * mean: 1.37 ng/ml imm2: * value obtained: 9.96 ng/ml * expected range: 10.2 - 15.4 ng/ml * mean: 12.8 ng/ml imm3: * value obtained: 37.09 ng/ml * expected range: 36.3 - 54.5 ng/ml * mean: 45.4 ng/ml the results obtained for imm1 and imm3 controls were in range according to manufacturer but showed a negative shift.For the imm2 control, it was below the range.Biomérieux data scientists calculated the new expected ranges taking into account the impact of improvement performed on new lots of vidas progesterone (starting from lot 1009323920).The updated values are: progestérone ng/ml - level 1: target at 1.10 ng/ml and range (0.88 ¿ 1.32) ng/ml - level 2: target at 10.3 ng/ml and range (8.2 ¿ 12.4) ng/ml - level 3: target at 36.5 ng/ml and range (29.2 - 43.8) ng/ml therefore, all results above from (b)(6) 2022 were within the new range.Between (b)(6) 2022 and (b)(6) 2022, the customer performed additional testing of level 1 (imm1), level 2 (imm2), and level 3 (imm3) with the new expected ranges.Eight (8) values for level 1 (imm1) were below the range with the following values: 0.83 / 0.85 /0.86 / 0.84 / 0.81 / 0.8 / 0.72 / 0.78.All values for level 2 (imm2) and level 3 (imm3) were within the new expected range.There is no patient associated with this external qc sample; therefore, there is no adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated.Note: reference 30409 is not registered in the united states.The u.S.Similar device is product reference 30409-01.

Manufacturer Narrative

This report was initially submitted following notification from a customer in colombia regarding underestimated results when testing with vidas® progesterone 60 tests (ref.30409, lot #1009453360, expiry date: 25-may-2023) in context of external quality control (randox immunoassay).The customer performed calibration of this kit (1009453360) and all values were within range.The calibration was valid.A biomérieux internal investigation has been completed with the following results: investigation outcomes.Complaint analysis.The complaint analysis did not reveal this issue as a systemic quality issue.Quality control records there is neither capa nor non-conformity linked to this issue on this vidas assay.3-3) analysis and tests conducted by complaints laboratory control chart analysis.This analysis was carried out: on six (6) internal samples with a respective target at 1.10 / 1.26 / 10.9 / 13.0 / 33.9 and 42.8 ng/ml.On at least nine (9) batches of vidas progesterone including the customer lot 1009453360.The analysis of the control charts showed that all results are within specifications and the lot mentioned by the customer is in the trend compared to the other lots.Tests performed using internal samples our complaints laboratory tested six (6) internal samples with different targets (same samples as mentioned above) on : vidas progesterone lot 1009453360 and lot 1009323920 as a reference.The results obtained complied to the expectations with no significant difference compared to the results observed before the batch release.So there is no evolution over time of the samples activity.Tests performed using quality control samples from biorad as part of the continuous improvement of our reagent, an adjustment of the calibration curve was implemented on vidas progesterone assay, starting from lot 1009323920, to be better correlated to the reference method gas chromatography mass spectrometry (gc-ms).Based on this information, our complaints laboratory tested quality control samples from biorad level 3 lot 40393 on different lots of vidas progesterone ref.30409.Lot 1009144570 (batch before the action) and lot 1009453360 (lot mentioned by the customer), lots 1009323920 and 1009591390 (lot used as a reference and also concerned by the action).The results obtained on vidas progesterone lot 1009144570 are higher than the ones observed on the three (3) other lots and within the range provided by biorad.The three (3) other lots, including the lot mentioned by the customer, gave results with no significant difference between them and these results are too low compared to the range provided by biorad.They are in accordance with the range recomputed by our datascience department taking into account the action implemented.Following the improvement, a customer service notification (csn 2022-005-0) with a customer letter was issued in june 2022 to inform customers about this action and that a slight drift may be observed when performing internal quality controls follow-up.It was recommended to adjust the acceptable ranges of these quality control materials (e.G.Apply a probatory period) when using vidas® progesterone kits, starting from the lot number 1009323930.Biomérieux also informed some quality control suppliers (e.G biorad) to inform them about the action.Regarding the issue observed on the external quality assessment program from randox (cycle 57/ sample id 3), without the quality control sample available, it is not possible to explain the result observed by the customer.Moreover, as it is not possible to have the detail of lots used by the vidas peers, we cannot know if the consensus value was obtained using mainly previous lots or new lots concerned by the action implemented.However, based on the analysis of complaints, there is no up rising trend of such issue.Conclusion.The customer's anomaly (namely underestimated results) was not reproduced when testing internal samples with different targets.Based on the different testing outcomes, the phenomena observed by the customer can be due to the action implemented on vidas progesterone reference 30409.According to the data mentioned above, there is no reconsideration of vidas progesterone lot 1009453360.

• Brand Name: VIDAS® PROGESTERONE 60 TESTS
• Type of Device: VIDAS® PROGESTERONE 60 TESTS
• 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: danielle cooper ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 15502976
• MDR Text Key: 301353191
• Report Number: 8020790-2022-00098
• Device Sequence Number: 1
• Product Code: JLS
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• 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: 11/10/2022
• 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: A
• Patient Sequence Number: 1