MAUDE Adverse Event Report: BIOMERIEUX, SA VIDAS® TSH

Model Number 30400

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456)

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

Event Date 06/26/2017

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) notified biom¿rieux that they observed discrepancies between results obtained in manual and automatic testing when using the product vidas¿ tsh (ref.30400) lot 1005459320.For sample m008 (male) the results were the following: - automatic mode: 1.56 and 2.13 ¿iu/ml.- manual mode: between 2.96 and 3.10 ¿iu/ml.- variation = cv: 23%.No change of interpretation: euthyroid.The final results transmitted were 2.96 ¿iu/ml for sample m008.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.A biom¿rieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification that a customer in (b)(6) contacted biom¿rieux to report observing discrepancies between results obtained in manual and automatic testing when using the product vidas¿ tsh (ref.30400) lot 1005459320.Investigational testing was performed.The patient samples were not submitted for investigation.So, the quality product laboratory tested two internal samples twice in automatic and manual pipetting mode on the retained vidas¿ tsh kit from lot 1005459320.The results obtained on the samples were similar between the automatic and manual pipetting mode.The quality product laboratory did not reproduce the customer's issue with the two internal samples.The vidas¿ tsh test kit, lot 1005459320/180117-0 performed as expected.The analysis of the logs (of apu and sections) showed no abnormal behavior of the instrument, nor difference between automatic and manual mode which could explain the difference in results observed by the customer.During the investigation, it was noted that there was 1.5 to 2.5 hours between the tests performed automatically (13:50 and 14:58) and those performed manually (16:31) on the patient samples.The investigation determined the root cause of the discrepant results to be the pre-analytical step (delay between samples tested in automatic mode and manual pipetting mode).After following advice provided by customer service, the customer obtained good results.All the results obtained with automatic and manual pipetting mode of the vidas¿ 3 instrument were correlated.The product quality laboratory did not reproduce the customer's anomaly.The internal investigation has confirmed the product performed within specification.

• Brand Name: VIDAS® TSH
• Type of Device: VIDAS® TSH
• Manufacturer (Section D): BIOMERIEUX, SA; 376 chemin de l'orme; marcy l'etoile, 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX, SA; 376 chemin de l'orme; marcy l'etoile, 69280 ; FR 69280
• Manufacturer Contact: ellen weltmer ; 595 anglum road; saint louis, MO 63042
• MDR Report Key: 6744692
• MDR Text Key: 81488418
• Report Number: 3002769706-2017-00205
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2017

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: 01/17/2018
• Device Model Number: 30400
• Device Lot Number: 1005459320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/27/2017
• Initial Date FDA Received: 07/26/2017
• Supplement Dates Manufacturer Received: 09/06/2017
• Supplement Dates FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1