MAUDE Adverse Event Report: BIOMERIEUX SA 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) notified biomérieux of a false positive result associated with vidas® gdh (reference (b)(4)).The customer reported while performing a correlation study between two (2) vidas®3 analyzers for vidas® gdh the discrepancy was observed.The results were as follows: sample 1: stool volume was not doubled; the liquid stool sample had clear separation and perfect supernatant.1st test on vidas® (b)(4) was obtained positive at 0.15.2nd test on vidas® (b)(4) was obtained negative at 0.00.Sample 2: doubled stool volume and volume of r1.1st test on vidas® 3 (b)(4) was obtained negative at 0.00.2nd test on vidas® 3 (b)(4) was obtained negative at 0.05.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in france had notified biomérieux of a false positive result associated with vidas® gdh (reference 30125).An internal biomérieux investigation was performed.Batch record review: there is no capa nor non-conformity recorded on vidas gdh 1006161620/190127-0 linked to the customer's issue.The analysis of the batch history records of vidas gdh 1006161620/190127-0 showed no anomaly during the manufacturing and control processes.Study of internal samples control charts: analysis was made on four (4) internal samples with different concentrations and on seven (7) batches including the batch mentioned by the customer.Vidas gdh batch 1006161620/190127-0 is in the trend analysis compared to the other batches.Testing by biomérieux: four (4) internal samples were tested (two stools to prepare gdh002 & gdh005 and two supernatants ready to use gdh027 & gdh031) and calibration on two (2) vidas 3 instruments.(b)(4).All of the results were within their specification and the same between the two (2) instruments.The vidas gdh 1006161620/190127-0 is within the expected performance.The customer's issue was not reproduced.Conclusion: according to the data mentioned above, vidas gdh, batch 1006161620/190127-0, performed as expected.

• Brand Name: VIDAS® 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: 7544663
• MDR Text Key: 109772016
• Report Number: 3002769706-2018-00070
• 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: 07/11/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 06/12/2018
• Supplement Dates FDA Received: 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1