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

Catalog Number 30409

Device Problem Non Reproducible Results (4029)

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

Event Date 10/25/2022

Event Type  malfunction  

Event Description

Intended use.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).Range of expected values.In a clinically healthy population, the following values were found: men 0.25 - 0.56 ng/ml.Women: follicular phase 0.25 - 0.54 ng/ml, luteal phase 1.5 - 20 ng/ml, ovulation 0.25 - 6.22 ng/ml, menopause < 0.41 ng/ml.These figures are given as a guide.It is recommended that each laboratory establishes its own reference values from a rigorously selected population.Description of the issue.On (b)(6) 2022, a customer in austria notified biomérieux of non-reproducible results when testing with vidas® progesterone 60 tests (ref.30409, lot #1009427820, expiry date: 20-may-2023) in context of patient samples for two (2) dogs.The customer uses mini vidas to analyze progesterone for dogs.Mle range.S: 1718 - 3067.C1: 3.4 - 5.38 ng/ml.Calibration performed on 26-oct-2022 was invalid.S: 2264.C1: 5.73 ng/ml.Vidas qcv test was valid on (b)(6) 2022.Result (patient 1) on (b)(6) 2022: 6.67 ng/ml 09:29 h.Result (patient 1) on (b)(6) 2022: 0.60 ng/ml 12:40 h.Result (patient 1) on (b)(6) 2022: 0.38 ng/ml 14:24 h.Result (patient 2) on (b)(6) 2022: 1.84 ng/ml 12:40 h.Calibration performed on (b)(6)2022 was valid.C1: 3.83 ng/ml.New blood collection on (b)(6) 2022.Result (patient 1) on (b)(6) 2022: 16.26 ng/ml 09:22 h.Result (patient 2) on (b)(6) 2022: 1.53 ng/ml 09:22 h.Second run on (b)(6) 2022.Patient 1: 13.51 ng/ml.Patient 2: 1.67 ng/ml.On (b)(6) 2022, a field service engineer (fse) checked the device and new leak (valid) optic (error 161) was changed.Calibration performed on (b)(6) 2022 was valid.S: 2265/2536/2328.C1: 4.30 ng/ml.At the time of this assessment, the customer has not provided any new results after the fse visit.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 austria regarding non-reproducible results when testing with vidas® progesterone 60 tests (ref.30409, lot #1009427820, expiry date: 20-may-2023) in context of patient samples for two (2) dogs.A biomérieux internal investigation has been completed with the following results: patient 1 results are between 0.60 ng/ml(3130 rfv) and 16.26 ng/ml (718 rfv) patient 2 results are between 1.53 ng/ml(2473 rfv) and 2.94 ng/ml (2013 rfv) all the results were obtained using the same lot of reagent and using two (2) calibrations (from 20th and 26th) for the calibration carried out on october 26th, c1 was out of range too high, however the c1 tested again on october was within range (3.83 ng/ml for [3.40-5.38]) 2) customers material no material received from the customer.3) investigation outcomes 3-1) complaint analysis as of the date of this investigation, only the customer¿s complaint has been recorded for reproducibility issue on vidas progesterone ref.30409 lot 1009427820.3-2) 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 five (5) internal samples with a respective target at 0.47/ 0.67/ 1.26 / 6.63 and 13.0 ng/ml (concentrations close to the values observed by the customer) using seven (7) batches of vidas progesterone ref.30409 including the customer¿s lot 1009427820.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.Test on internal samples the complaints laboratory tested four (4) internal samples with the following targets 0.47 / 1.26 / 5.81 and 13.0 ng/ml (targets close to the concentrations observed by the customer) on the retain kit of progesterone ref.30409 lot 1009427820 (lot mentioned by the customer).The results complied with the specifications without any significant difference compared to those observed before the batch release.No evolution over time was observed of these samples activity.Repetition testing the complaints laboratory tested a sample from a blood donor (low concentration about 0.30 ng/ml) in repetition six (6) times.The results observed were distributed between < 0.25 and 0.35 ng/ml and neither the high results observed by the customer nor the very high variability observed on canine samples were reproduced.There is no canine sample available in our laboratory to test.Conclusion the complaints laboratory did not reproduce the issue reported by the customer (non-reproducible results) when testing internal samples on vidas progesterone ref.30409 lot 1009427820.The high variability observed by the customer was not reproduced when testing a blood donor sample in repeatability.Without the customer¿s material available, it was not possible to further pursue the investigation.No obvious root cause has been identified.It is possible that the issue has a multifactorial root cause combining: the quality control sample processed by the customer (e.G aspect, stability, homogenization, and handling).The instrument (respect of instructions of use related to preventive maintenance and monitoring with weekly qcv testing).The calibration results.It is mentioned in the package insert of vidas progesterone ref.30409 at section specimen stability: ¿it is recommended not to use samples that are clearly hemolyzed, lipemic or icteric, and if possible, to collect a new sample.¿ according to the data mentioned above, there is no reconsideration of vidas progesterone ref.30409 lot 1009427820.

• Brand Name: VIDAS® PROGESTERONE 60 TESTS
• Type of Device: VIDAS® PROGESTERONE 60 TESTS
• 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: 15771356
• MDR Text Key: 304782840
• Report Number: 8020790-2022-00107
• Device Sequence Number: 1
• Product Code: JLS
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2023
• Device Catalogue Number: 30409
• Device Lot Number: 1009427820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1