MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GN TEST KIT

Catalog Number 21341

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Event Description

A customer from the (b)(6) reported to biomérieux a misidentification of citrobacter amalonaticus as serratia odorifera, for a blood culture from a dialysis patient, in association with vitek 2 gn test kit.The technicians determined the isolate was not serratia odorifera based on culture smell, which prompted testing of the isolate with an alternative method (microscan).The result was citrobacter amalonaticus.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.The customer sent the test reports to biomérieux and sent the isolate to an external lab for testing.A field service engineer was scheduled to visit the customer site.A biomerieux internal investigation has been initiated.

Manufacturer Narrative

A customer from the united states reported to biomérieux a misidentification of citrobacter amalonaticus as serratia odorifera in association with vitek® 2 gn test kit.An internal biomérieux investigation was performed.The organism was subbed and testing included both the customer lot and a random lot of vitek® 2 gn cards.Api® 20 e was performed, as was vitek® ms and 16s sequencing.On both cards tested, an excellent id (99%) of s.Odorifera was obtained.Api® 20 e gave a good identification to the genus of pantoea.Vitek® ms gave an identification of leclercia adecarboxylata (99.9% confidence value).However, when 16s sequencing was performed, a 99% identity match to both enterobacter amnigenus and leclercia sp.Was obtained.A comparison of card reaction results for s.Odorifera against the expected reaction results for e.Amnigenus resulted in one (1) atypical positive reaction (ellm).A comparison of card reaction results for s.Odorifera against the expected reaction results for l.Adecarboxylata resulted in two (2) atypical positive reactions (dsor, cit).Conclusion: atypical strain.

• Brand Name: VITEK® 2 GN TEST KIT
• Type of Device: VITEK® 2 GN TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6354825
• MDR Text Key: 68367209
• Report Number: 1950204-2017-00067
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: C1, EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2017
• Device Catalogue Number: 21341
• Device Lot Number: 241390940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2017
• 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