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

Catalog Number 21341

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from the united states reported to biomérieux a misidentification of an api (american proficiency institute) survey sample of proteus vulgaris, as proteus penneri in association with the vitek® 2 gn id test kit.The repeated test result was proteus penneri.The customer stated they had a low discrimination and performed an indole test on the organism, which was negative indicating proteus penneri.The test reports were requested from the customer.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

Biomérieux conducted an internal investigation: the organism was tested on multiple lots of gn cards in duplicate.The api® 20 e was performed, as was the vitek® ms.On 2 of the customer lots, a low discrimination call of p.Penneri / p.Hauseri was obtained.On the remaining 2 customer lots tested and the random lot, a low discrimination call of p.Penneri / p.Pneumotropica was obtained.Api® 20 e gave a good identification call of p.Vulgaris group.Vitek® ms gave a low discrimination call of p.Penneri / p.Vulgaris.Since the organism is indole positive, the vitek® ms call of p.Vulgaris would be correct.A comparison of reaction results for cards giving the misidentification call of p.Penneri / p.Hauseri against the expected reaction results for p.Vulgaris revealed 3 atypical negative reactions (ple, ilatk, aglu).A comparison of reaction results for cards giving the misidentification call of p.Penneri/p.Pneumotropica against the expected reaction results for p.Vulgaris revealed 4 atypical negative reactions (proa, ple, ilatk, aglu).This is an atypical isolate.A complaint history review was completed for this issue during the last 13 month timeframe with no implication of a trend.No further action is warranted at this time.

• Brand Name: VITEK® 2 GN ID TEST KIT
• Type of Device: VITEK® 2 GN ID TEST CARD
• 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: 6266493
• MDR Text Key: 65387581
• Report Number: 1950204-2017-00019
• 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: 02/15/2017

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: 08/27/2017
• Device Catalogue Number: 21341
• Device Lot Number: 241391140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2016
• Initial Date FDA Received: 01/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2016
• 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