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 in (b)(6) notified biomerieux of discrepant identification results when testing an eeq strain (external quality control eeq prospective, strain reference: ebu (b)(4)) with vitek® 2 gp id test kit (reference (b)(4)).The customer stated that when he tested the eeq strain (catalase negative and oxydase negative) on the impacted card lot of vitek 2 gp id cards, he obtained different identifications of kocuria kristinae, aerococcus urinae or streptococcus alactolyticus.He obtained those different identifications several times when he tested this strain on vitek 2 with the impacted gp id card lot and also on vitek 2 compact (lot.# unknown).Of note, as of the date of this report, this eeq survey is still ongoing.The customer obtained the following results: on (b)(6) 2018: on vitek 2 compact: kocuria kristinae species (94%) on the impacted lot #2420510103 of vitek 2 gp card: kocuria kristinae species (88%) as the catalase negative of the eeq strain did not match with a kocuria species (catalase positive), the customer performed a retest on vitek 2 compact only and obtained: aerococcus urinae (89%).On (b)(6) 2018: to confirm his result: aerococcus urinae species, he performed a third test and obtained the following results: on vitek®2 compact: kocuria kristinae (88%) and aerococus urinae (89%) on the impacted lot #2420510103 of vitek 2 gp card: streptococcus alactolyticus (89%) and kocuria kristinae (88%) there is no indication or report from the laboratory that the discrepant quality result led to any adverse event related to any patient's state of health.There was no patient associated with this quality control sample.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed due to a potential non-reproducibility of identifications for eeq strain ebu 2018-1 on vitek® 2 v7.01 gp cards.The submitted isolate was subcultured and vitek 2 gp card testing included individual organism suspensions on one (1) customer lot (cl : 2420510103) and one (1) random lot (rl : 2420571103), tested 3 times each.Vitek® ms was also performed.The identification was confirmed to aerococcus urinae (99.9%) with vitek ms v3 (knowledge base v3.0).On vitek 2 (v7.01) gp cards, four (4) out of the six (6) gp cards gave an acceptable identification of kocuria kristinae, duplicating the customer's misidentification.The remaining cards gave an unidentified organism and a good identification to aerococcus urinae.The non-reproducibility of identification for this strain was confirmed in-house.Vitek 2 results demonstrate a degree of variability in the gp card reaction wells leading to the misidentifications.A review of the customer's misidentification profiles demonstrated two (2) atypical positive reactions (amy, and sal) for an identification of aerococcus urinae according to the gp knowledge base.An increased number of atypical positive reactions can indicate contamination, mixed culture, use of non- recommended media, user set up errors, or an atypical strain.Atypical profiles compared to the vitek 2 gp knowledge base.

• 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: 7323690
• MDR Text Key: 102221275
• Report Number: 1950204-2018-00093
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420510103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 03/08/2018
• Supplement Dates Manufacturer Received: 08/02/2018
• Supplement Dates FDA Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2017
• 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