MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (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 in (b)(6) reported misidentifications for a quality control staphylococcus aureus strain (atcc® 29213¿) in association with the vitek®2 gp test kit (lot 2420565103).The customer stated they used columbia agar (cos) from oxoid (18h aerobic incubation) and obtained misidentifications of aerococcus viridans and enterococcus faecalis.Biomérieux instructed to retest the strain from tsab agar, and use the recommended atcc strains for the gp card lot qc.The customer tested the recommended atcc strains and the qc passed.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in germany reported misidentifications for a quality control staphylococcus aureus strain (atcc® 29213¿) in association with the vitek®2 gp test kit (lot 2420565103).An investigation was performed.The customer reported setting up the strain from cos agar from oxoid after incubating for 18 hours at 37c.The customer obtained their strain from a kwikstick.No reference method was performed to check the identification of the strain.After the customer retested the strain on a different lot of gp cards (2420554103), the organism was identified correctly.Note: s.Aureus atcc 29213 is not a qc strain for the gp card.Three (3) lab reports were submitted with one showing a correct identification of s.Aureus.One lab report showed a good identification of a.Viridans with six (6) atypical negative reactions (drib, adh1, pyra, aglu, phos, baci) for an identification of s.Aureus according to the gp knowledge base.Another lab report showed an excellent identification of e.Faecalis with seven (7) atypical positive reactions (amy, alaa, novo, tyra, aspa, dsor, sal) for an identification of s.Aureus according to the gp knowledge base.An increased number of atypical reactions can indicate contamination, mixed culture, compromised viability of the strain, use of non recommended media or other user set up errors or an atypical strain.However without the strain or raw data it's not possible to further evaluate the cause of the misidentification.The vitek 2 gp lot #2420565103 met final qc release criteria and passed initial qc performance testing.

• Brand Name: VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT
• Type of Device: VITEK® 2 GP ID CARD
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 7291745
• MDR Text Key: 101138979
• Report Number: 1950204-2018-00080
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: CL. I EXEMPT
• 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: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420565103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2017
• 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