MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 GP (GRAM-POSITIVE) ID TEST KIT

Catalog Number 21342

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) reported a misidentification of staphylococcus aureus as staphylococcus pseudintermedius in association with the vitek® 2 gp (gram-positive) id test kit (lot 2420686403).The customer reported that the gp id card identified s.Pseudintermedius and both vitek ms and api® identified s.Aureus.The test was repeated on two vitek 2 instruments and the results were s.Pseudintermedius.Both instruments were recently serviced and passed qc.The customer stated the patient result was not affected and there was a 24 hour delay due to repeat testing.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal investigation was reported for a misidentification of staphylococcus aureus as staphylococcus pseudintermedius in association with the vitek 2 gp (gram-positive) id test kit (lot 2420686403).The customer's strain was subcultured to remel tsab agar and incubated at 35-37° in ambient atmosphere for 18-24 hours.In addition to the staphylococcus species present, it was noted that one alpha hemolytic colony was present as well, which was a likely contaminant and therefore not tested.A second subculture was performed on the staphylococcus colonies.Testing included vitek 2 gp card on the customer lot 2420686403 and a random lot, 2420587103, at s/w version 8.01 as well as vitek ms testing.911782 (15615670) was tested on the customer and random lots.Three of the four gp id cards ran gave a low discrimination identification of staph.Aureus/s.Chromogenes/s.Pseudintermedius with the fouth card giving a final low discrimination identification of staph.Aureus/s.Chromogenes.The staphylococcus was also identified via vitek ms as staphylococcus aureus with 99.9% confidence value.As the correct identification was included in the low discrimination call, vitek 2 cards are performing as intended.Review of the customer's biochemical reactions showed one atypical positive reaction (leua) for an identification of s.Aureus according to the gp knowledge base.An atypical reaction can indicate a strain with decreased viability, contamination, mixed culture, use of non-recommended media or other user set up error.

• Brand Name: VITEK® 2 GP (GRAM-POSITIVE) ID TEST KIT
• Type of Device: VITEK® 2 GP (GRAM-POSITIVE) ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: debra broyles ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 7949735
• MDR Text Key: 123948453
• Report Number: 1950204-2018-00417
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: C1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420686403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2018
• 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