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 cap survey strain enterococcus gallinarum in association with the vitek® 2 gram-positive (gp) identification (id) test kit.The initial vitek® 2 gp id test obtained a low-discrimination result of enterococcus casseliflavus / enterococcus gallinarum.The test suggested performing a hippurate test, but instead the customer repeated the gp id test and obtained a result of enterococcus casseliflavus.The customer reported the enterococcus casseliflavus result to cap.Upon receipt of the cap survey summary indicating the correct result was enterococcus gallinarum, the customer pulled a second sample from the survey strain and tested again via vitek® 2 gp id; the result was a low-discrimination result of enterococcus casseliflavus / enterococcus gallinarum.This time, the customer acted as instructed and performed a hippurate test which was positive for 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 will be initiated.

Manufacturer Narrative

A customer in the united states contacted biomérieux to report a misidentification of cap survey strain enterococcus gallinarum in association with the vitek® 2 gram-positive (gp) identification (id) test kit.An internal biomérieux investigation was performed.The internal cap reconstituted sample was subcultured and gp testing included individual organism suspensions on two cards from five (5) different lots.The api® 20 strep was also performed although it does not identify e.Casseliflavus or e.Gallinarum without supplemental testing.Nine (9) of the 10 gp cards tested resulted in low discrimination calls of e.Casseliflavus/e.Gallinarum.Vitek® 2 proposed additional testing to separate these species.The isolate did not demonstrate yellow pigmentation and tested hip positive on the api test kit, resulting in an identification of e.Gallinarum.The remaining card gave an excellent identifications of e.Gallinarum.The investigation concluded that vitek® 2 gp cards performed 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: 6298311
• MDR Text Key: 66503847
• Report Number: 1950204-2017-00043
• 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,Followup
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420056403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2016
• 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