MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® TSH

Catalog Number 30400

Device Problem Non Reproducible Results (4029)

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

Event Type  malfunction  

Event Description

On 05-aug-2021, a customer in (b)(6) notified biomérieux of a reproducibility issue when testing with vidas® tsh (tsh) (ref#: 30400), (lot #:1008634080, expiry date: 15mar2022) with a patient sample.1st test : (b)(6) 2021, 9.43 iu/ml, 2nd test : (b)(6) 2021, 5.99 iu/ml.According to a related case from the same customer the calibration performed on (b)(6) 2021 was valid.However, per global customer service (gcs) the rfv of standard and the c1 result are a little bit high according to mle range.The customer is being sent another kit to test the samples to see if the results are reproduced.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 30400 is not sold or distributed in the united states.However, there is a similar device, u.S-only product reference, 30400-01.

Manufacturer Narrative

An internal investigation was initiated following notification, from a customer in the republic of korea, of a reproducibility issue when testing with vidas® tsh (tsh) (ref#: (b)(4)), (lot #:1008634080, expiry date: 15mar2022) with a patient sample.The customer's sample was not submitted for the investigation.Investigation: the analysis of the batch history records of vidas tsh lot 1008634080 showed no anomaly during the manufacturing, control and packaging processes.No non-conformities nor capas can be linked to the customer¿s complaint recorded on vidas tsh lot 1008634080.Control chart analysis: the investigator analyzed the control charts for 4 internal samples (including at 6.06 ui/ml and 8.92 ui/ml) using seven test lots (including the lot being used by this customer).All values are within specifications; customer¿s lot is consistent with the other lots.Internal sample tests: the complaints laboratory tested 2 internal samples targeted at 6.06 ui/ml and 8.92 ui/ml on retain kit vidas tsh lot 1008634080.Results obtained are within the acceptable ranges and there is no evidence the values have drifted since the lots were released for distribution.Next, the complaints laboratory tested retain kit vidas tsh lot 1008634080, using the internal samples targeted at 6.06 ui/ml and 8.92 ui/ml on 5 different positions in the same run of vidas pc.First sample: mean = 5.82 , ui/ml cv = 1.29% results obtained between 5.71 and 5.90 ui/ml.Second sample: mean = 8.93, ui/ml cv = 1.08% results obtained between 8.76 and 9ui/ml.The vidas tsh package insert states, in section on precision, that for a level of vidas tsh concentration = 8.28, iu/ml, the within-run reproducibility cv = 2.8%.Conclusion: the complaints laboratory did not reproduce the customer¿s anomaly.No anomalies were highlighted with the control chart analysis, the analysis of quality data and the tests performed on our internal quality control materials on the retain kit vidas tsh lot 1008634080.The package insert, section limitations of the method, states: "interference may be encountered with certain sera containing antibodies directed against reagent components.The results of a tsh assay must be interpreted as part of a complete clinical profile.In case of discrepancy, this assessment must be completed by thyroid hormone measurement." vidas tsh lot 1008634080 is within the expected performance.

• Brand Name: VIDAS® TSH
• Type of Device: VIDAS® TSH
• 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: candace martin ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 12409003
• MDR Text Key: 283252170
• Report Number: 8020790-2021-00179
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K141133
• 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: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2022
• Device Catalogue Number: 30400
• Device Lot Number: 1008634080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1