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

Model Number 30400-01

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in the united states notified biomérieux that they have observed falsely low results for a patient's sample in association with the vidas® tsh 60 tests (ref.#: (b)(4), lot #:1007944800) compared to results obtained by an external laboratory.The customer stated that they had tested a patient tsh sample on their vidas, the results were as follows: patient 1: vidas result = 0.08 (units not reported).Repeat analysis with the vidas tsh obtained the same results.The sample was then sent to an external laboratory for reference testing as the customer indicated that the vidas results did not match the last time the tsh was ran for the patient.The external laboratory results were as follows: patient 1: labcorp result = 4.08 (units not reported).The customer was unsure, which test method was used by the external laboratory.The customer reported that no incorrect results were reported to the treating physician, there was no delay in reporting results, and this event did not lead to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

B1 was initially set to "adverse event" in error.B1 has been corrected to "product problem".

Manufacturer Narrative

Biomerieux conducted an internal investigation in response to a customer complaint of falsely underestimated results for two separate patients in association with the vidas® tsh 60 tests (ref 30400-01, batch 1007944800).The analysis of the batch history records showed no anomalies during the manufacturing, quality control, or packaging processes.There were no capa or nonconformities linked to the customer's complaint.A study on six (6) internal sera control charts on seven (7) vidas tsh batches, including the lot of the customer¿s (vidas® tsh lot 1007944800/ 210224-0) was performed.All of the results were within specifications.Vidas® tsh 1007944790 / 210224-0 was in trend compared to the other batches.Biomerieux requested the customer to return their samples; however, the sample was not available.According to the analysis of the control charts, and results obtained on the internal and biorad samples, the performance of vidas® tsh lot 1007944800/ 210224-0 is within the expected specifications.The investigation did not reproduce the underestimated tsh values obtained by the customer.There have been no similar complaints reported for vidas® tsh lot 1007944800.The investigation data supports that vidas® tsh lot 1007944800/ 210224-0 is functioning as intended.

• Brand Name: VIDAS TSH
• Type of Device: VIDAS® TSH
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; 69280 ; FR 69280
• MDR Report Key: 11032295
• MDR Text Key: 241258535
• Report Number: 8020790-2020-00139
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 03573026156886
• UDI-Public: 03573026156886
• Combination Product (y/n): N
• PMA/PMN Number: K141133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2021
• Device Model Number: 30400-01
• Device Catalogue Number: 30400-01
• Device Lot Number: 1007944800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1