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

Catalog Number 21341

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

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

Event Date 11/27/2015

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) reported the vitek 2 gram-negative (gn) id test kit provided inconsistent identification results for a single patient isolate.The initial gn id test obtained a result of klebsiella oxytoca.The customer always performs an indole test for this organism; the result was negative, which the customer considered odd for this organism id.The customer retested the isolate via gn id card; the repeat test provided klebsiella pneumoniae.Both gn id cards were inoculated from the same blood culture bottle.Klebsiella oxytoca was reported to the physician despite the negative indole result; this is because of the excellent identification (98%) reported by the vitek 2 gn id card.The customer performed no testing of the isolate via alternate method.Therefore; there is no confirmation of either result.Biomerieux has requested submittal of patient isolate for internal testing.There is no indication or report from the hospital or treating physician to biomerieux that the organism misidentification led to any adverse event related to the patient's state of health.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

Biomérieux internal investigation was conducted.Testing included the customer lot and two (2) random lots of vitek® 2 gn id cards.Api® 20 e was also performed.On the customer lot and one random lot of gn id cards, an id of klebsiella pneumoniae ssp pneumoniae was obtained.On the second random lot of gn id cards, an id of klebsiella oxytoca was obtained.Api® 20 e gave an id of klebsiella pneumoniae ssp pneumoniae.Therefore, the final identification is k.Pneumoniae ssp pneumoniae.A comparison of reaction results for the card giving the klebsiella oxytoca identification against the expected reaction results for klebsiella pneumoniae ssp pneumoniae revealed one atypical positive reaction (5kg) that contributed to the misidentification.It should also be noted that the analysis time for the card giving a klebsiella oxytoca identification (3.75 hours) was much shorter than that for cards giving the correct identification (8.25-8.50 hours).The investigation concluded that the patient isolate is an atypical strain having irregular or inconsistent growth characteristics.The vitek® 2 gn id cards are performing as expected.

• Brand Name: VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 GN 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: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5366270
• MDR Text Key: 36060515
• Report Number: 1950204-2016-00007
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: CL. I EXEMPT
• 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: 12/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2016
• Device Catalogue Number: 21341
• Device Lot Number: 241356410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2015
• 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