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

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

A customer in (b)(6) notified biomérieux of obtaining low results for a patient when using the vidas® tsh (reference # 30400, lot # 1007887960, expiry date 29 jan 2021) and comparing with other methods.The customer reported that they obtained low vidas tsh results for a patient having a history of hypothyroidism with the following results : on vidas tsh : 0.10 uiu/ml.On vidas ft4 : 18.71 (unit not reported).The patient went to another lab (reference lab in india) and the tsh result was obtained at 6.32 uiu/ml (method unknown).Then, the customer sent the same first sample to another laboratory where they had both beckman immunoanalyser and minividas and the results were as follows : on beckman immunoanalyser : 6.63 uiu/ml.On vidas tsh : 0.40 uiu/ml.The customer sent the same sample to another laboratory where they had mini vidas and tsh value came as 0.30 uiu/ml.The customer sent the same sample to another laboratory having tosoh immunoanalyser and the tsh value was obtained at 6.90 uiu/ml.It was recommended to the customer to dilute the sample and run the same in order to remove any interference.The customer diluted the sample 1:5 and the calculated vidas tsh value came out to be as 6.22 uiu/ml on the same minividas.An application support manager went to the customer site and centrifuged the sample and the results obtained were as expected.The customer was reminded to centrifuge the sample.It is possible the testing performed at other labs obtained the expected results because they were centrifuging their samples properly.The package insert states to "mix the calibrator, control and samples using a vortex-type mixer (for serum or plasma separated from the pellet)".The customer has obtained the expected results since they began to properly centrifuge the samples.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 registered in the united states.The u.S.Similar device is product reference 30400-01.

Manufacturer Narrative

Biomerieux conducted an internal investigation in response to a customer complaint of an underestimated patient result obtained using the vidas® tsh 60 tests (ref.(b)(4), lot 1007887960).The analysis of the batch history records for the vidas tsh ref (b)(4) 1007887960 / 210129-0 showed no anomaly during the manufacturing, control and packaging processes directly linked with the customer's issue.There were no capa or nonconformities related the discrepancy experienced by the customer.Analysis of six internal sera control charts on seven vidas batches, including customer lot 1007887960 / 210129-0 was performed.All of the results were within specifications.Vidas® tsh 1007887960 / 210129-0 was in trend compared to the other lots.The complaint laboratory tested two internal samples on the retain kit vidas® tsh lot 1007887960 / 210129-0.Results obtained were within the acceptable ranges, and comparable to those observed before the batch release.Biomerieux also tested 5 all-round efs sera using lot 1007887960 / 210129-0, euthyroid results were provided for all samples.The investigation data supports that vidas® tsh lot 1007887960 / 210129-0 is functioning as intended.

• Brand Name: VIDAS TSH
• Type of Device: VIDAS® TSH
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 10908761
• MDR Text Key: 252620548
• Report Number: 8020790-2020-00128
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• PMA/PMN Number: K141133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2021
• Device Catalogue Number: 30400
• Device Lot Number: 1007887960
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1