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 from italy reported a misidentification of a clostridium sporogenes (atcc® 11437) internal quality control strain as low discrimination organism in association with the vitek® 2 anc test kit.The customer stated that the anc card gave a low discrimination organism result five times.The customer had performed one qc which was compliant.The customer used cba medium for 24 hours then subcultured and inoculated the strain on anc cards.The gram stain was gram positive bacilli.The customer had cleaned the optics and the vitek system did not give any errors.There was no patient involvement as the event pertained to a quality control strain.The instructions for use (ref.043907-02), indicates the atcc 11437 c.Sporogenes strain is not recommended for anc cards.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was initiated due to a low discrimination result with quality control strain clostridium sporogenes atcc 11437 on vitek® 2 v7.01 anc card.The customer tested a strain that is not a biomérieux recommended strain for anc quality control.The expected identification to clostridium sporogenes was confirmed on vitek® ms v3 (kb v3.0).On vitek 2 (v7.01) anc cards, one (1) card of customer lot (cl : 2440223403) and one (1) card of random lot (rl : 2440320203) were tested from cos subculture with anaerobic environment.These tests gave: -low discrimination between cl.Bifermentans and cl group with the cl.-unidentified organism with the rl.Conclusion: the customer result was reproduced in-house on the cl, with low reactivity of the strain: atypical strain.

• 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: 7522627
• Report Number: 1950204-2018-00188
• Device Sequence Number: 1545033
• Product Code: JSP
• UDI-Device Identifier: 03573026144364
• UDI-Public: 03573026144364
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 09/04/2018

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: 07/07/2018
• Device Catalogue Number: 21347
• Device Lot Number: 2440223403
• 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: 04/18/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1