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 the united states contacted biomérieux to report a misidentification of enterococcus gallinarum (cap survey strain d-15) as enterococcus casseliflavus in association with the vitek® 2 gram-positive (gp) identification (id) test kit.Repeat testing obtained a low-discrimination result of enterococcus casseliflavus / enterococcus gallinarum.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 cap survey strain.Biomérieux investigation was conducted.This isolate was not submitted by the customer; therefore, the internal lyophilized cap sample was reconstituted and tested.Investigational testing included: · vitek® 2 gp id (four customer lots and a random internal lot): nine (9) of ten (10) cards provided a low-discrimination result of enterococcus casseliflavus / enterococcus gallinarum.Vitek 2 proposed additional testing to separate these species.The remaining gp id test kit provided a result of enterococcus gallinarum.· api® strep: the isolate did not demonstrate yellow pigmentation and tested hip positive on the api test kit, resulting in an identification of enterococcus gallinarum.The investigation concluded the vitek® 2 gp id cards are performing as expected.

• 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: 6267840
• MDR Text Key: 65466241
• Report Number: 1950204-2017-00026
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420063403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2016
• 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