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

Catalog Number 30409

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Event Description

On (b)(6) 2022, a customer in (b)(6) notified biomérieux of overestimated result when testing with vidas® progesterone 60 tests (ref.30409, lot #1008911230, expiry date: 05-jul-2022) in context of external quality control.Sample 41: customer value: 64.9 nmol/l.Target: 44.5 nmol/l.Lower limit: 28.9 nmol/l.Upper limit: 60.1 nmol/l.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 will be initiated.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 germany regarding an overestimated result when testing with vidas® progesterone 60 tests (ref.30409, lot #1008911230, expiry date: 06-aug-2022) in context of external quality control (eqc sample 41 from instand).Sample 41 : 64.9 nmol/l ; expected range : 44.5 nmol/l [ 28.9-60.1] a biomérieux internal investigation has been completed with the following results: investigation 1.Complaint analysis and device history record: the review did not highlight any issue during manufacturing, control and packaging processes for vidas progesterone ref.30409 lot 1008911230.At the time of this investigation, no similar complaints are registered on the vidas progesterone ref.30409 lot 1008911230.The analysis of the control charts performed on four (4) internal samples and seven (7) batches, including the one of customer, showed that all results were within specifications.The customer¿s lot was in the trend of the other lots.Prg10 : target = 16.2 ng/ml (51.5 nmol/l ) ; range =[14.18-18.22] ng/ml prg16 : target = 14.6 ng/ml (46.4 nmol/l) ; range =[12.76-16.44] ng/ml prg11 : target = 5.75 ng/ml (18.3 nmol/l) ; range =[4.91-6.59] ng/ml prg023 : target = 8.34 ng/ml (26.5 nmol/l) ; range =[7.21-9.47] ng/ml 2.Investigation the customer's sample was not available to be returned for the investigation.** the batch mentioned by customer is expired so it is impossible to perform tests.Moreover the batch is mentioned in the fsca 5333-1 related to the substrate error.The new expiration date was 05jul2022.3.Root cause analysis the results observed by the customer was most likely related to an adjustment made to calibration of vidas® progesterone kit.As part of continuous improvement of our reagents, biomérieux decided to adjust the calibration of vidas® progesterone kit to be better correlated to the reference method gas chromatography mass spectrometry (gc-ms).Customer service notification (csn) 2022-005 - vidas® progesterone calibration adjustment was published in august 2022 as notification of this adjustment.The action is now implemented, starting from lots 1009323920 and 1009323930.Therefore, the distribution of vidas peer group will be impacted for future external quality control assessment.Two populations could be observed depending on vidas® progesterone batches used, before or after the readjustment.According to the above data, the kit vidas progesterone ref.30409 lot 1008911230 was within the expected performances.

• 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: 15218852
• MDR Text Key: 301262714
• Report Number: 8020790-2022-00089
• Device Sequence Number: 1
• Product Code: JLS
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2022
• Device Catalogue Number: 30409
• Device Lot Number: 1008911230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1