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

Catalog Number 21347

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 biomérieux of the misidentification of a probioqual external quality control sample, 17ca2a, when testing with vitek® 2 anc test kit (ref 21347).The expected identification is corynebacterium urealyticum.The customer stated they tested twice with vitek 2.They initially obtained a result of "unidentified organism," and the second result was 99% clostridium group.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

This report was initially submitted following notification by a customer in (b)(6) of the misidentification of a probioqual external quality control sample, 17ca2a, when testing with vitek® 2 anc test kit (ref 21347).The expected identification was corynebacterium urealyticum.The customer stated they tested twice with vitek 2.They initially obtained a result of "unidentified organism," and the second result was 99% clostridium group.Biomérieux internal investigation was conducted using the strain submitted by the customer.Two (2) types of colonies were observed: - colony a (small colonies and thin growth) - colony b (large colonies) investigational testing included: - vitek ms: colony a obtained identification to corynebacterium urealyticum (99.9%) : intended result.Colony b obtained identification to staphylococcus saprophyticus (99.9%) : likely a contaminant - vitek 2 anc id (customer lot 2440318203 and random lot 2440320203) performed only on colony a: obtained excellent identification to corynebacterium urealyticum for both anc id card lots.The customer misidentification to clostridium group was not reproduced.The investigation concluded the vitek 2 anc id card is performing as intended.

• Brand Name: VITEK® 2 ANC TEST KIT
• Type of Device: VITEK® 2 ANC 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: jeff scanlan ; 595 anglum road; hazelwood, MO 63042 ; 3147318694
• MDR Report Key: 7179165
• MDR Text Key: 97736823
• Report Number: 1950204-2018-00016
• Device Sequence Number: 1
• Product Code: JSP
• UDI-Device Identifier: 03573026144364
• UDI-Public: 03573026144364
• 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: 05/11/2018

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: 10/10/2018
• Device Catalogue Number: 21347
• Device Lot Number: 2440318203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 01/10/2018
• Supplement Dates Manufacturer Received: 04/17/2018
• Supplement Dates FDA Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2017
• 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