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

On 18-jun 2023, a customer from jordan notified biomérieux of obtaining potential overestimated results when testing patient samples with vidas progesterone 60 tests (ref.30409, batch number: 1009863160, expiry date: 18-jan-2024).Six (6) samples were tested on (b)(6) 2023 evening and the results showed a concentration > 80 ng/ml with an abnormal rfv: 0 or 1.There was no issue on the background noise of the reading well (substrate bck assessed) found between 143 and 147 rfu (specs are < 500 rfu).The calibration used to read these samples was the one performed on the same day just before testing the samples: s1 rfv: 2898-2865-2850, mean: 2871 ; specs [1991-3555].C1: 5.15 ng/ml : specs [3.65-5.75] ng/ml.The calibration was valid but the control 1 (c1) was noted to be higher in the acceptable range.Due to the strange results obtained on (b)(6) 2023, these six (6) samples were re-measured in the morning on (b)(6) 2023 and showed a concentration consistent with the clinical profile: - sample 1: rfv: 3651 ; conc= 0.51 ng/ml ; bck: 146 - sample 2: rfv: 3727 ; conc= 0.42 ng/ml; bck: 144 - sample 3: rfv: 3825 ; conc= 0.32 ng/ml ; bck: 147 - sample 4: rfv: 3707 ; conc= 0.44 ng/ml; bck: 145 - sample 5: rfv: 3836 ; conc= 0.31 ng/ml ; bck: 144 - sample 6: rfv: 4154 ; conc= < 0.25 ng/ml; bck: 144 due to the clear anomaly on the measurements on (b)(6) 2023, a potential root could be due to the absence of sprs.According to global customer service (gcs), when the sprs is missing, the rfu is generally close to 1 and conc > 80 ng/ml.As the problem occurred on six (6) successive tests on same day, it seems to be a user error in which the customer forgot to place the sprs in the block.The situation came back to normal the day after most likely because no reagent was forgotten.However, at the time of this assessment this has not been confirmed with the customer.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be 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 jordan regarding potential overestimated results when testing patient samples with vidas progesterone 60 tests (ref.(b)(4), batch number: 1009863160, expiry date: 18-jan-2024).A biomérieux internal investigation has been completed with the following results: device history record: there was no non-conformity and no capa on vidas progesterone 60 tests - 30409, lot 1009863160 related to the customer's complaint.Complaint analysis: the complaint analysis did not reveal this issue as a systemic quality issue.Tests/analysis performed.Products return: the kit was not returned by the customer for testing.Control chart analysis: the complaints laboratory analyzed four (4) internal samples on seven (7) batches of vidas progesterone 60 tests - 30409, including the lot 1009863160 mentioned by the customer with the following targets:1.26 ng/ml, 0.91 ng/ml, 0.30 ng/ml and 0.47 ng/ml.The analysis of the control charts showed that all results were within specifications.The lot 1009863160 was in the trend of the other lots.Test on internal samples: the complaints laboratory tested four (4) internal samples with the following targets 0.30 -0.47 - 0.91-1.26 ng/ml, on the retain kits of vidas progesterone 60 tests - 30409, lot 1009863160 (customer¿s lot).Results obtained on lot 1009863160 were within the acceptable ranges and similar to those observed before the batch release.No evolution was observed over time for the batch.Based on this experiment, it was confirmed that the customer lot was still within specification.Test without sprs: according to internal studies, there is evidence that when the sprs is missing, the rfu is generally close to 1 and conc > 80 ng/ml.The complaints laboratory launched three (3) tests with the strip but without its associated sprs to be compared to the customer results.Test results without a spr gave a rfv of 0 or 1 with a concentration >80 ng/ml.These results were compliant with internal studies and reproduced the customer issue.Root cause analysis and conclusion: according to all information above, no anomaly was highlighted with the control chart analysis or the tests performed on internal samples with the kit vidas progesterone 60 tests - 30409, lot 1009863160.When the spr is missing, the rfu is generally close to 1 and conc > 80 ng/ml (checked by internal documentation for troubleshooting).As the problem occurred on six (6) successive tests on the same day at the customer site, it seems to be a user error in which the customer forgot to place the sprs in the block.The situation returned to normal the day after, and the hypothesis is because no reagent was forgotten.According to the information mentioned above, there is no reconsideration of the performance for vidas progesterone 60 tests - 30409, lot 1009863160.

• 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: danielle cooper ; 595 anglum rd; hazelwood, MO 63042
• MDR Report Key: 17325400
• MDR Text Key: 320052982
• Report Number: 8020790-2023-00043
• Device Sequence Number: 1
• Product Code: JLS
• Combination Product (y/n): N
• Reporter Country Code: JO
• 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: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2024
• Device Catalogue Number: 30409
• Device Lot Number: 1009863160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1