MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS TSH 60 TESTS; VIDAS® TSH 60 TESTS

Catalog Number 30400

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Note: reference 30400 is not registered in the united states.The u.S.Similar device is product reference (b)(4).A customer in (b)(6) notified biomérieux of potentially discrepant results for nine separate patients in association with the vidas® tsh 60 tests (ref.30400, lot 1007770820).The patient samples were tested using the lot 1007770820 and via the roche test method.The customer stated the results obtained with vidas® tsh 60 tests lot 1007770820 were lower than the results obtained with the roche test method for all nine (9) samples.Biomérieux customer service reviewed the data provided from the customer; the review determined good correlation and the same interpretations were obtained across both test methods for patients two (2) through nine (9).The review determined the results from patient one (1) showed a different interpretation between the vidas® tsh 60 tests lot 1007770820 and the roche method.Two separate samples were obtained from the patient, and each sample was tested using both test methods.Results are listed below; units were not provided.Patient 1 sample 1.Vidas® lot 1007770820 result: 0.05.Roche test method result: 0.77.Patient 1 sample 2.Vidas® lot 1007770820 result: 0.16.Roche test method result: 1.58.There is no indication or report from the laboratory that the discrepant results led to any adverse event related to any patient's state of health.Biomérieux will initiate an internal investigation.

Manufacturer Narrative

Section g4 was not completed in initial report 8020790-2020-00077.The customer contact date was (b)(6) 2020.Section g4 has been filled in to capture this information.

Manufacturer Narrative

This report was initially submitted following notification from a customer in jordan regarding potentially discrepant results for nine separate patients in association with the vidas® tsh 60 tests (ref.(b)(4), lot 1007770820).The patient samples were tested using the lot 1007770820 and via the roche test method.The customer stated the results obtained with vidas® tsh 60 tests lot 1007770820 were lower than the results obtained with the roche test method for all nine (9) samples.Biomérieux customer service reviewed the data provided from the customer; the review determined good correlation and the same interpretations were obtained across both test methods for patients two (2) through nine (9).The review determined the results from patient one (1) showed a different interpretation between the vidas® tsh 60 tests lot 1007770820 and the roche method.Two separate samples were obtained from the patient, and each sample was tested using both test methods.A biomérieux internal investigation has been completed with the following results: the analysis of the batch history records for the lot vidas tsh ref (b)(4), 1007770820/201201-0 showed no anomaly during the manufacturing, control and packaging processes.Internal samples control charts were analyzed on four internal sera (euthyroid status) with different concentrations: 0.50 ui/ml-0.57 ui/ml-0.57 ui/ml-0.64 ui/ml.The analysis was carried out on seven (7) different vidas tsh batches including the lot mentioned by the customer.All values were within specifications and the customer's lot was in the trend of the other lots.The complaints laboratory also tested four (4) internal samples (euthyroid status) on retain kit vidas tsh lot 1007770820/201201-0.Tsh5 = 0.52 ui/ml target 0.57 (range 0.39 - 0.75 ui/ml); tsh12 = 0.58 ui/ml target 0.64 (range 0.45 - 0.83 ui/ml); tsh21 = 0.48 ui/ml target 0.50 (range 0.33 - 0.67 ui/ml); tsh43 = 0.44 ui/ml target 0.56 (range 0.38 - 0.74 ui/ml).The results obtained were within the acceptable range and in the euthyroid status with similar results compared to those obtained before the batch release.There is no reconsideration of the performance of vidas tsh reference (b)(4), lot 1007770820/201201-0.The samples were not available to be returned by the customer so the discrepant result between vidas and roche technique regarding patient 1 cannot be investigated further.

• Brand Name: VIDAS TSH 60 TESTS
• Type of Device: VIDAS® TSH 60 TESTS
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280, ; FR
• MDR Report Key: 10404810
• MDR Text Key: 204364330
• Report Number: 8020790-2020-00077
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• PMA/PMN Number: K921816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2020
• Device Catalogue Number: 30400
• Device Lot Number: 1007770820
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 07/15/2020; 10/22/2020
• Supplement Dates FDA Received: 08/14/2020; 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1