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 proficiency test urine sample of proteus vulgaris, as proteus penneri in association with the vitek® 2 gn id test kit.The organism was cultured 24-48 hours on bap/tsab/blood agar, using mcfarland range 0.5-0.63.The customer repeated the test with an 18-24 hour culture, using mcfarland 0.60 and 0.57.The identification result was proteus penneri.The vitek®2 gn test reports and the proficiency results were requested from the customer.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: the organism was tested on multiple lots of gn cards in duplicate, including four (4) lots reported by customers and one (1) random gn lot.The api 20 e was performed, as was the vitek® ms.On two (2) of the customer lots, a low discrimination call of p.Penneri / p.Hauseri was obtained.On the remaining two (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.

• 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: 6262452
• MDR Text Key: 65218257
• Report Number: 1950204-2017-00013
• 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: 09/15/2017

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: 03/02/2017
• Device Catalogue Number: 21341
• Device Lot Number: 241373140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/23/2016
• Initial Date FDA Received: 01/18/2017
• Supplement Dates Manufacturer Received: 01/25/2017
• Supplement Dates FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2016
• 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