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 Known Impact Or Consequence To Patient (2692)

Event Date 03/29/2018

Event Type  malfunction  

Event Description

A customer in (b)(6) reported a misidentification when testing two blood cultures from one patient, in association with the vitek® 2 gp test kit (lot 2420650203).On (b)(6) 2018, the first culture was twice identified as enterococcus faecium (98%).And the second culture result was low discrimination staphylococcus hominis.The strain was cocci gram positive and catalase positive.The customer performed testing from (b)(6) cna agar + 5% sheep blood, and chromid® cps agar.The customer believed the colony from the first culture looked like a staphylococcus, so the strain was sent to the reference laboratory for testing with vitek ms, and was identified as staphylococcus hominis.The customer stated a result of staphylococcus hominis was reported to the physician without delay, there is no indication or report from the customer that the misidentification impacted the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification by a customer in (b)(6) of a misidentification when testing two blood cultures from one patient, in association with the vitek® 2 gp test kit (lot 2420650203) and software version 7.01.On (b)(6) 2018, the first culture was twice identified as enterococcus faecium (98%) and the second culture result was low discrimination staphylococcus hominis.Biomérieux internal investigation was conducted using the strain submitted by the customer.16s sequencing obtained an organism identification to the species staphylococcus hominis.Vitek ms v3 (knowledge base v3.2) obtained an organism identification to the species staphylococcus hominis.Vitek 2 gp id (customer lot 2420650203 and random lot 2420758203) were tested from two different media (tsab and cpse).Tsab: - customer lot test 1 : low discrimination between aerococcus viridans , staphylococcus epidermidis and staphylococcus hominis ssp hominis.- customer lot test 2 : very good identification to staphylococcus epidermidis 94%.- random lot test 1 : excellent identification to staphylococcus haemolyticus 99%.- random lot test 2 : very good identification to staphylococcus hominis ssp hominis 93%.Cpse: customer lot : very good identification to aerococcus viridans 94 %.Random lot : very good identification to aerococcus viridans 93 %.The customer misidentification to the species enterococcus faecium was not reproduced during the investigation.The expected identification to staphylococcus hominis was obtained twice (cl test 1-tsab and rl test2-tsab).Other results demonstrate variability in the gp id card reaction wells leading to the misidentifications.The investigation concluded the strain exhibits atypical growth characteristics.

• Brand Name: VITEK® 2 GP TEST KIT
• Type of Device: VITEK® 2 GP 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: jeff scanlan ; 595 anglum road; hazelwood, MO 63042 ; 3147318694
• MDR Report Key: 7639094
• MDR Text Key: 112848290
• Report Number: 1950204-2018-00238
• 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: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420650203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2018
• 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