MAUDE Adverse Event Report: BIOMÉRIEUX SA VIDAS® PROGESTERONE

Catalog Number 30409

Device Problem Low Test Results (2458)

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

Event Type  malfunction  

Event Description

On 02-may-2023, a customer in algeria notified biomérieux that they observed underestimated results when testing patient samples using vidas progesterone 60 tests (ref.(b)(4), batch number 1009452770, expiry date 07-jun-2023) compared to other methods.The blood sampling was performed in the context of monitoring ovarian stimulation in assisted medical procreation (amp).Results obtained with vidas progesterone 60 tests (ref.(b)(4)) lot 1009452770: sample id: (b)(6) results on 29-apr-2023: result at 09:09 am (section b1): < 0.25 ng/ml.Result at 10:28 am (section b1): < 0.25 ng/ml.Sample id: (b)(6), result on 29-apr-2023: result at 09:09 am (section b2): < 0.25 ng/ml.Result at 10:28 am (section b2): < 0.25 ng/ml.Sample id: (b)(6), results on 29-apr-2023: result at 09:09 am (section b3): 0.35 ng/ml result at 10:28 am (section b3): 0.25 ng/ml these results were preceded by a valid calibration performed on (b)(6) 2023.Qcv results from 02-may-2023 were provided and were conform.The vidas results were inconsistent with the clinical status of the patients, therefore the physician performed testing using two other methods: cobas (roche) and maglumi.The results using these methods were within the expected ranges and consistent with the clinical status of the patients.At the time of this assessment, the patients¿ clinical context was not known, and correlation between cobas, maglumi results and patient samples was not known.There is no indication or report that the issue led to any adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.Note: reference (b)(4) 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 performed following a notification from a customer in algeria regarding under-estimated results in vidas progesterone 60 tests - 30409, lot 1009452770, expiry date 07-jun-2023) on 3 patient samples compared to 2 competitors (roche & maglumi).Investigation results 1.Complaint analysis the complaint analysis did not reveal this issue as a systemic quality issue.2.Tests/analysis performed it was not possible to pick-up the 3 samples from the customer for testing at biomérieux's complaints laboratory.2.1) test on internal samples biomérieux's complaints laboratory tested 3 internal samples with targets 0.31 ng/ml ; 1.10 ng/ml and 6.63 ng/ml using retained kits of vidas progesterone 60 tests -'ref.(b)(4)) lot 1009452770 (customer¿s lot).The results were within the acceptable ranges and similar to those observed before the batch's release.No evolution over time of the batch was observed.2.2) control chart analysis the complaints laboratory analyzed 4 internal samples on 7 batches of vidas progesterone 60 tests (ref.30409) including the lot mentioned by the customer with the following targets 0.31 ng/ml ; 1.10 ng/ml ; 6.63 ng/ml; 1.26 ng/ml.The analysis of the control charts showed that all results are within specifications.The lot 1009452770 is in the trend of the other lots.2.3) analysis of external quality control samples biomérieux's complaints laboratory subscribes to different eqa schemes and tests several quality control samples just like a regular user.The complaints laboratory tested 4 external quality control samples from probioqual (french external quality control provider) on another lot of vidas progersterone in 2022.Roche /vidas (peers comparison with probioqual ¿ 2022) sample (b)(6) vidas : target : 4.757 nmol/l ; range [3.806-5.708] nmol/l roche :target : 4.662 nmol/l ; range [3.73-5.594] nmol/l sample (b)(6) vidas : target :93.55 nmol/l ; range [79.52-107.58] nmol/l roche :target :74.29 nmol/l ; range [63.15-85,43] nmol/l sample (b)(6): vidas : target : 23.811 nmol/l ; range [19.049-28.573] nmol/l roche :target :22.773 nmol/l ; range [18.218-27.328] nmol/l sample (b)(6) vidas : target : 3.129 nmol/l range [nd] roche : target :3,677 range [2.942-4.412] nmol/l the low values in progesterone are similar between roche and vidas while they tend to be different for the high values.3.Root cause analysis and conclusion according to all information above, no anomaly was highlighted with the control chart analysis, the analysis of quality data and the tests performed on internal samples with the kit vidas progesterone 60 tests (ref.(b)(4)) lot 1009452770.Moreover, there is no recurrence of the customer's issue on this batch.Nevertheless, in absence of samples from the customer, it was not possible to find any root cause related to an underestimation and reproduce the customer's issue.As per vidas progesterone' package insert: ¿limitations of the method concentration values of progesterone obtained should be used for diagnosis in association with additional information gathered by the physician (questions, symptoms, current drug therapy, clinical observations, other examinations, etc).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¿.According to all data, there is no reconsideration of the performance of vidas progesterone 60 tests (ref.(b)(4)) lot 1009452770.

• 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: dima amro ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 16912601
• MDR Text Key: 315275177
• Report Number: 8020790-2023-00033
• Device Sequence Number: 1
• Product Code: JLS
• Combination Product (y/n): N
• Reporter Country Code: AG
• 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: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2023
• Device Catalogue Number: 30409
• Device Lot Number: 1009452770
• 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: 06/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1