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

Catalog Number	21347
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: VITEK® 2 ANC TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• MDR Report Key: 7179165
• Report Number: 1950204-2018-00016
• Device Sequence Number: 1249707
• Product Code: JSP
• UDI-Device Identifier: 03573026144364
• UDI-Public: 03573026144364
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 10/10/2018
• Device Catalogue Number: 21347
• Device Lot Number: 2440318203
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1