MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT; VITEK® 2 ANC CARD

Catalog Number 21347

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) reported a misidentification of an (b)(6) proficiency specimen (actinobaculum shaalii) as actinomyces meyeri in association with the vitek 2 anc id card.There is no indication or report from the hospital to biomerieux that the discrepant result led to any adverse event related to any patient's state of health.No patient was directly associated with the (b)(6) proficiency result.Proficiency organism submittal has been requested by biomerieux for internal investigation.Biomerieux investigation will be conducted.

Manufacturer Narrative

Internal investigation was conducted (ansm actinobaculum schaalii survey strain #657, lot 2).The organism was sub-cultured, and testing included: vitek® 2 anc id card.16s sequencing (reference method) to determine the intended result.Results: 16s sequencing confirmed the expected identification to species actinobaculum schaalii.Identification to species actinomyces meyeri was obtained by vitek® 2 anc id (with vitek 2 systems software version 6.01).Identification to species actinobaculum schaalii was obtained by vitek® 2 anc id (with vitek 2 systems software version 7.01).The misidentification to actinomyces meyeri was duplicated using the customer software version 6.01; actinobaculum shaalii is not claimed in the version 6.01 knowledge base.The vitek® 2 6.01 product information manual (ref.410791) indicates which organisms can be identified using the vitek® 2 anc id card; actinobaculum schaalii is not listed.Per the vitek® 2 product information manual, "testing of unclaimed species may result in an unidentified result or misidentification." for any organism placed into a test card, the vitek® 2 system will assess the card readings against the known organisms and provide an organism identification, if possible, based on a combination of growth well reactions.For results with a percent confidence of <99%, the customer must make a determination of acceptance or further testing based on the logical likelihood of the identification considering other laboratory and clinical factors.The vitek® 2 anc id card is performing as intended within the scope of product specifications.

• Brand Name: VITEK® 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 ANC 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: 5128226
• MDR Text Key: 27491596
• Report Number: 1950204-2015-00057
• Device Sequence Number: 1
• Product Code: JSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: D031836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Report Date: 09/22/2015

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: 21347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2015
• 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