MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 GRAM POSITIVE ID TEST KIT; VITEK® 2 GP ID 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) notified biomérieux of misidentification results when testing with the vitek® 2 gp id test kit (reference 21342, lot 2420416403).The customer was testing an aerococcus viridans cap quality control strain, and vitek 2 provided an identification of staphylococcus lentus.As there was no patient directly associated with this quality control strain, there is no adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from (b)(6) had notified biomérieux of misidentification results when testing with the vitek® 2 gp id test kit (reference 21342, lot 2420416403).The customer was testing an aerococcus viridans cap quality control strain, and vitek 2 provided an identification of staphylococcus lentus.An internal biomérieux investigation was performed.The customer did not submit their strain for investigation as repeat testing provided the correct result.Additional information received identified the customer strain as cap d-16, 2017.Since this strain was available internally, it was used for the investigation testing.The biomérieux internal cap d-16, 2017 strain was rehydrated, subcultured to tsab agar and incubated at 35-37° c, in co2 atmosphere.A second subculture was performed and vitek 2 gp testing included individual organism suspensions with cards from the two (2) customer lots (2420563203, 2420416403) and a random lot (2420435103), in duplicate.Vitek® ms was also performed.A total of six (6) vitek 2 gp cards were tested, all resulting in excellent, very good and acceptable identifications of aerococcus viridans.Vitek ms also resulted in an identification of aerococcus viridans with a 99.9% confidence value.A review of the customer's s.Lentus reactions showed two (2) atypical positive reactions (amy, dxyl) for an identification of a.Viridans according to the vitek 2 gp knowledge base.A review of the customer's leuconostoc mesenteroides reactions showed one (1) atypical positive reaction (dxyl) and two (2) atypical negative reactions (dmal, dmne) for an identification of a.Viridans according to the vitek 2 gp knowledge base.The customer's reported discrepancies were not reproduced.Vitek 2 gp cards performed as expected for this strain.

• Brand Name: VITEK® 2 GRAM POSITIVE ID TEST KIT
• Type of Device: VITEK® 2 GP ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 7447379
• MDR Text Key: 106862212
• Report Number: 1950204-2018-00150
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420416403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2017
• 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