MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT; VITEK® 2 GP ID CARD

Catalog Number 21342

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in ireland contacted biomérieux to report a misidentification of neqas survey organism enterococcus gallinarum as enterococcus casseliflavus in association with the vitek® 2 gram-positive (gp) identification (id) test kit.Repeat test obtained the same result.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.There was no patient directly associated with the neqas survey sample.Culture submittal was requested by biomérieux for internal investigation.Biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) contacted biomérieux to report a misidentification of (b)(6) survey organism enterococcus gallinarum as enterococcus casseliflavus in association with the vitek® 2 gram-positive (gp) identification (id) test kit.An internal biomérieux investigation was performed.On a (b)(6) survey ((b)(6)), 74% of biologists reported enterococcus gallinarum, on gp card (vitek® 2 software version v7.01): misidentification as enterococcus casseliflavus.The organism was subcultured on cba media and coh media, tested on 16s sequencing, vitek® ms, and on four (4) different lots of vitek® 2 gp cards.The vitek® 2 gp cards tested in-house, gave on 5/8 tests, a low discrimination between enterococcus gallinarum and enterococcus casseliflavus , with one (1) test against cdex for e.Gallinarum.For 3/8 tests (cl2 and cl3), vitek® 2 gp cards gave excellent identification to enterococcus gallinarum (98%).The customer's result was not duplicated: misidentification to enterococcus casseliflavus on vitek® 2, but the low discrimination between these 2 species, e.Gallinarum and e.Casseliflavus, was reproduced.Remark: the cdex test negative is atypical on vitek® 2 and confirmed on rapid id32strep strip.The non-yellow pigmentation of the colony is in favor of e.Gallinarum (complementary test recommended); atypical strain.Per internal testing, the identification to the species e.Gallinarum was well confirmed on sequencing and on vitek® ms.

• Brand Name: VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 GP ID 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; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 5997438
• MDR Text Key: 56394015
• Report Number: 1950204-2016-00140
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K952095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 21342
• Device Lot Number: 242394310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1