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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) reported a misidentification of corynebacterium macginleyi from a patient isolate (eye sore), as proponobacterium acnes in association with the vitek® 2 anc test kit 20cards (lot 2440440103).The customer stated that while testing a gram positive bacillus strain from the patient isolate on cos and can media, a growth was observed that suggested a potential corynebacterium species.The customer tested the strain on the anc card, and an identification of proponobacterium acnes (95%) was obtained.The customer sent the strain to the national reference center for testing and the result was corynebacterium macginleyi by mass spectrometry.No incorrect result was reported to the clinician, but there was a 48 hour delay in reporting results due to complementary testing.Corynebacterium macginleyi species is not a claimed species for vitek 2 anc cards.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was performed due to the misidentification of a corynebacterium macginleyi as propionibacterium acnes on the vitek® 2 v7.01 anc card.The species corynebacterium macginleyi is not included in anc knowledge base (kb).The intended result to corynebacterium macginleyi was confirmed on vitek® ms v3 (kb v3.0).This species is not included in the vitek 2 anc kb.The anc card package insert contains the following limitation statement: "warning: testing of unclaimed species may result in an unidentified result or a misidentification.".

• Brand Name: VITEK® 2 ANC TEST KIT
• Common Device Name: VITEK® 2 ANC TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; st. louis MO 63042
• MDR Report Key: 7461442
• Report Number: 1950204-2018-00162
• Device Sequence Number: 1147489
• Product Code: JSP
• UDI-Device Identifier: 03573026144364
• UDI-Public: 03573026144364
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K910666
• 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): 08/15/2018

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: 02/09/2019
• Device Catalogue Number: 21347
• Device Lot Number: 2440440103
• 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: 04/03/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1