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

A customer from (b)(6) notified biomérieux of obtaining an underestimated result when testing a patient sample using vidas® tsh (ref (b)(4), lot 1007856870) in conjunction with their vidas system.The customer said that on (b)(6) 2020, they had tested a patient sample for the determination of tsh and that they had obtained a value of 0.06 miu/l.The customer mentioned that the physician questioned the result based on the patient's history.The customer mentioned that on (b)(6) 2020 a new sample from the same patient was tested by an external laboratory using an alternative commercially available technique that found tsh value of 1.49 mu/l (range 0.55 - 4.78 mu/l).The customer reported that on (b)(6) 2020 they had tested the same sample tested by the external laboratory using the same vidas® reagent and system and that they had obtained a tsh value of 0.1 miu/l.It was noted by the customer that the wrong results were reported to the physician; however, there is no indication or report from the customer or the treating physician to biomérieux that the underestimated result led to any adverse event related to the patient's state of health.A biomérieux internal investigation has been initiated.Note: reference (b)(4) is not registered in the united states.The u.S.Similar device is product reference (b)(4).

Manufacturer Narrative

A customer from switzerland notified biomérieux of obtaining underestimated results for two of a patient¿s samples using vidas® tsh (ref 30400, lot 100785687 / 210117-0) as compared to results from a competing technique (siemens).An internal biomérieux investigation was performed.According to the analysis of the quality data, the vidas tsh 100785687 / 210117-0 batch does not present any anomaly during the stages of manufacture, control and packaging.Control card analysis performed on six internal samples (target 0.05 iu / ml; 1.47 iu / ml; 0.57 iu / ml; 5.74 iu / ml; 0.13 iu / ml; 0.20 iu / ml) and eight lots including the client's lot, showed that the vidas tsh 100785687 / 210117-0 lot is in the trend of the other lots.In the absence of a customer sample return, three samples from the internal panel as well as two ciq biorad samples were tested on vidas tsh kit vidas tsh 100785687 / 210117-0.The results comply with the standards for each sample.No drift of the lot since its release.The customer's anomaly was not reproduced for vidas tsh, kit 100785687 / 210117-0.The possibility of interference of the sample with vidas tsh reference 30400 could not be ruled out.The package insert states, in the chapter ¿limitations of the method: 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.The investigation found that vidas tsh, kit 100785687 / 210117-0, is performing as intended.

• 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: 10497241
• MDR Text Key: 206514075
• Report Number: 8020790-2020-00082
• 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
• Report Date: 10/28/2020

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: 01/17/2021
• Device Catalogue Number: 30400
• Device Lot Number: 1007856870
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 09/04/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1