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 (b)(6)contacted biomerieux to report a misidentification of (b)(6) survey organism (distribution (b)(6)) enterococcus gallinarum as enterococcus casseliflavus in association with the vitek 2 gram-positive (gp) identification (id) test kit.Repeat test obtained the same result.The (b)(6) summary report for the referenced distribution indicated 28% of 184 laboratories in the distribution scope misidentified enterococcus gallinarum as enterococcus casseliflavus.The expected organism (e.Gallinarum) was identified via maldi-tof at (b)(6).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 (b)(6) survey sample.Culture submittal was requested by biomerieux for internal investigation.Biomerieux investigation was conducted.Investigational testing included the following: - sequencing 16s: identification to enterococcus gallinarum 100% confirmed intended (b)(6) result.- vitek ms: enterococcus gallinarum 99.9% - vitek 2 gp id (three customer lots and one random lot from cba media): customer lot 1 - low discrimination between enterococcus gallinarum and enterococcus casseliflavus customer lot 2 - one low discrimination between enterococcus gallinarum and enterococcus casseliflavus, and one excellent identification to enterococcus gallinarum (98%) customer lot 3 - one low discrimination between enterococcus gallinarum and enterococcus casseliflavus, and one excellent identification to enterococcus gallinarum (98%) random lot - low discrimination between enterococcus gallinarum and enterococcus casseliflavus - api 20 strep (two different lots), each lot tested three times): very good identification to the species enterococcus faecium, possibility of enterococcus casseliflavus or enterococcus gallinarum if vancomycin resistant.- rapid id32strep (lot 1004430390): good identification to enterococcus gallinarum 99.8% with the vitek 2 gp id cards tested in-house obtained, on 5/8 tests, a low discrimination between enterococcus gallinarum and enterococcus casseliflavus.For 3/8 tests, the vitek 2 gp id cards obtained excellent identification to enterococcus gallinarum (98%).The investigation did not duplicate the discrepant customer result (misidentification to enterococcus casseliflavus).The low-discrimination calls achieved are acceptable (not incorrect) and lead the user to further identification testing.The investigation concluded the vitek 2 gp id cards are performing as intended.

Manufacturer Narrative

A customer in the united states reported the occurrence of false positive esbl (extended spectrum beta-lactamase) phenotype in association with the vitek® 2 ast-gn84 test kit while testing a klebsiella pneumoniae isolate.As the patient was being treated with aztreonam, the physician asked for repeat testing.The physician modified the patient therapy to meropenem.An internal biomérieux investigation was performed.This k.Pneumoniae isolate was submitted for esbl evaluation because the vitek® 2 ast-gn84 cards gave positive esbl results, but kirby bauer esbl disk testing gave negative results.Identification of the organism was confirmed, and testing included both the customer lot and a random lot of ast-gn84 cards.Clsi esbl disk testing, which is the reference method for the esbl test, was also performed.On both cards tested, a negative esbl result was obtained.Clsi esbl disk testing was also negative, so card and reference method are in agreement.Cards are performing as expected and no further action is necessary.

Manufacturer Narrative

A customer in (b)(6) contacted biomérieux to report a misidentification of neqas survey organism (distribution 3926) 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 neqas survey (distribution 3926 sample 3250), 74% of biologists reported enterococcus gallinarum, on vitek® 2 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, on vitek® 2 with four (4) different lots of 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.And 3/8 tests (cl2 and cl3), gp cards gave excellent identification to enterococcus gallinarum(98%).The customer result was not duplicated : misidentification to enterococcus casseliflavus on vitek® 2, but the low discrimination between these two (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.In house, 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: 6083993
• MDR Text Key: 59847669
• Report Number: 1950204-2016-00168
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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,Followup
• Report Date: 10/12/2016

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 Catalogue Number: 21342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 11/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/05/2016; 12/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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