MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 GP TEST KIT

Catalog Number 21342

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported a misidentification of a streptococcus mitis quality control sample ((b)(6)) in association with the vitek® 2 gp test kit.The customer reported the lyophilized specimen was subbed out twice (as required by (b)(6)), before any testing was done on the isolate.The customer performed offline biochemical testing and the results were: pyr-, lap+, esc-, opt-resistant, bile solubility-r, alpha colonies and gpc in chains.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from canada reported a misidentification of a streptococcus mitis quality control sample (iqmh) in association with the vitek® 2 gp test kit.An investigation was performed.The customer's submitted strain was subcultured to tsab agar and two different colony morphologies were observed, a larger and a smaller colony, both alpha-hemolytic and testing was performed on both colony types.Testing included individual organism suspensions with gp cards from the customer's lot (2420409403) and a random lot (2420542103), vitek ms and api 20 strep kit.Note: both colony types were very dry and flaky and suspensions remained very particulate rather than the recommended homogenous inoculum.A total of six gp cards were tested, resulting in identifications of s.Mitis/s.Oralis (slashline) on one card, low discrimination: s.Mitis/s.Oralis/s sanguinis on two cards, low discrimination: s.Mitis/s.Oralis/s.Pneumoniae on one card, and unidentified organism on two cards.While the slashline and low discrimination identifications are considered correct, the customer's unidentified organism results were duplicated.A review of the customer's streptococcus thoraltensis reactions demonstrated five atypical positive reactions (amy, dxyl, dman, mbdg, dtre) for an identification of s.Mitis according to the gp knowledge base.A review of the customer's streptococcus pneumoniae reactions demonstrated four atypical positive reactions (amy, sal, pyra, dtre) for an identification of s.Mitis according to the gp knowledge base.A review of the customer's gemella morbillorum reactions demonstrated three atypical negative reactions (leua, dgal, sac) for an identification of s.Mitis according to the gp knowledge base.A review of the customer's three unidentified organism reports demonstrated three (pyra, sal, dtre) seven (amy, dxyl, pyra, dman, mbdg, sal, dtre) and four (dman, mbdg, sal, dtre) atypical positive reactions for an identification of s.Mitis according to the gp knowledge base.An increased number of atypical positive reactions can indicate contamination, mixed culture, use of non-recommended media or other user set up errors or an atypical strain.An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain.The investigation concluded the submitted isolate has an atypical biochemical profile.

• Brand Name: VITEK® 2 GP TEST KIT
• Type of Device: VITEK® 2 GP TEST KIT
• 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 ; 100 rodolphe street; durham, NC 27712
• MDR Report Key: 7335966
• MDR Text Key: 102754227
• Report Number: 1950204-2018-00100
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: 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: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420409403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2017
• 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