MAUDE Adverse Event Report: BIOMERIEUX SA 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

A customer in (b)(6) notified biomérieux of obtaining falsely underestimated results for two samples from one patient in association with vidas® tsh test kit (ref 30400, lot 1007567330).The customer stated both samples were tested using the vidas® tsh test kit and obtained results of 0.07uui and 0.08uui.The roche test method at an external laboratory obtained a result of 1.79miu.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.Biomérieux has initiated an internal investigation.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint of obtaining falsely underestimated results for two samples from one patient in association with vidas® tsh test kit (ref 30400, lot 1007567330).Two samples were submitted by the customer for the investigation.The complaint laboratory performed testing on internal samples as well as the customer's samples with multiple lots including the customer's lot.All test results from internal samples were within specification and did not indicate an issue with the product.Testing the customer's samples reproduced the customer's issue for one sample, but not for the second sample.The investigation concluded that the cause for the falsely underestimated results was not related to a specific lot of product, but rather an interference present in the patient sample.No further investigation into the source of the interference could be completed as there was not enough sample for additional testing.See h10 for addtl mfg narrative.

• 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, 69280 ; FR 69280
• MDR Report Key: 9862863
• MDR Text Key: 207754123
• Report Number: 8020790-2020-00034
• Device Sequence Number: 1
• Product Code: LYR
• 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: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2020
• Device Catalogue Number: 30400
• Device Lot Number: 1007567330
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1