MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® C. DIFFICILE GDH; VIDAS® GDH

Catalog Number 30125

Device Problem False Positive Result (1227)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) reported to biomérieux that they obtained a false positive result when using the product vidas® gdh (ref.30125), lot 1006161620.The customer performed a correlation study between two vidas 3 analyzers (vidas (b)(4) and vidas (b)(4)) for vidas gdh.The results were obtained as follows: sample 1: stool volume not doubled: 1st test on vidas (b)(4) was obtained positive at 0.25, 2nd test on vidas (b)(4) was obtained negative at 0.00.Sample 2: doubled stool volume and volume of r1: 1st test on vidas (b)(4) was obtained negative at 0.00 (non-standard c1 control), 2nd test on vidas (b)(4) was obtained negative at 0.00 (non-standard c1 control).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 biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted in response to a customer report from france that the vidas® gdh assay provided a false positive result for a patient stool specimen.Biomérieux investigation was conducted.Evaluation of the manufacturing batch records indicated there was no anomaly or nonconformance during the manufacturing, control or packaging processes.Investigational testing of four (4) internal samples against seven (7) vidas gdh batches (including the customer's batch number) obtained results within the documented performance specifications and showing no drift as compared to previous testing.Testing was performed on two (2) different vidas 3 instruments.The investigation did not reproduce the customer's result of false positive.The vidas gdh assay performed as intended.The product instructions for use (ifu), "specimens" section state: "it is critical that stool specimens be thoroughly mixed before sample processing is begun.Lack of homogeneity in a stool sample may lead to incorrect results.Thorough mixing of stool specimens is essential to avoid this problem.The diluted sample must be homogeneous after mixing.This will help ensure valid results.For this sample preparation step, it is essential to check the amount of deposited sample regardless of the consistency of the stools (liquid, semi-solid or solid).If the customer complaint another time, propose him to send a fas to remind the different protocole specifique for each kind of stool.".

• Brand Name: VIDAS® C. DIFFICILE GDH
• Type of Device: VIDAS® GDH
• Manufacturer (Section D): BIOMERIEUX SA; 376, chemin de l'orme; marcy l'etoile, 69280 ; FR 69280
• MDR Report Key: 7674193
• MDR Text Key: 113910850
• Report Number: 3002769706-2018-00104
• Device Sequence Number: 1
• Product Code: MCB
• Combination Product (y/n): N
• PMA/PMN Number: K132010
• 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: 01/08/2019

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: 01/27/2019
• Device Catalogue Number: 30125
• Device Lot Number: 1006161620
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 07/10/2018
• Supplement Dates Manufacturer Received: 12/13/2018
• Supplement Dates FDA Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1