MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK 2 GP ID TEST KIT; VITEK 2 GP ID CARD

Catalog Number 21342

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported a discrepancy with a proficiency sample result associated with the vitek®2 ast-gp67 card.The sample organism enterococcus faecium was identified as enterococcus durans.The test was repeated with the proficiency sample, on two (2) vitek®2 systems, which confirmed enterococcus durans.The customer stated they use oxoid blood agar media and incubate 24 hours.The proficiency sample test reports and the isolate were requested from the customer.There is no indication or report from the customer that a patient was directly associated with the proficiency sample result.An internal biomérieux investigation has been initiated.

Manufacturer Narrative

A customer from (b)(6) reported a discrepancy with a proficiency sample result associated with the vitek®2 ast-gp67 card.The sample organism enterococcus faecium was identified as enterococcus durans.An internal biomérieux investigation was performed.The submitted isolate was subcultured and testing included two (2) vitek® 2 ast-gp cards from the customer's lot, two (2) cards from a random lot, api 20 strep kit and vitek® ms.The four (4) vitek® 2 ast-gp cards tested resulted in very good identifications of enterococcus durans.Exper/essay 5491-60.The api strep testing resulted in a very good identification to the genus of enterococcus durans.Vitek® ms identified the isolate as enterococcus faecium.A review of the customer's enterococcus durans data against the expected reactions for enterococcus faecium demonstrated three (3) atypical negative reactions (bgal, dman, and dtre).A review of the internal gp testing of the isolate demonstrated two (2) atypical negative reactions (dman and dtre) contributing to the misidentification.Root cause: atypical strain.A complaint history review was completed for this issue during the last 13 month timeframe with no implication of a trend.The most recent quarterly trend review did not identify this complaint as a systemic quality issue.

• Brand Name: VITEK 2 GP ID 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: 6096957
• MDR Text Key: 59907597
• Report Number: 1950204-2016-00175
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/13/2016

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 Expiration Date: 09/20/2017
• Device Catalogue Number: 21342
• Device Lot Number: 242393320
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 11/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1