MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK®2 GP TEST KIT

Catalog Number	21342
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomerieux of a misidentification associated with vitek® gp test kit (reference 21342).The customer reported observing an incorrect identification of globicatella sanguinis for an actinotignum schaalii eeq ctcb survey strain.The strain was tested on three (3) different agar plates: cna (presence of colonies), chocolate (presence of colonies), cps (absence of colonies).The customer reported not performing routine quality control checks.A gram stain was performed prior to card set up and found gram-positive cocci and catalase negative.As indicated in the ctcb survey instructions actinotignum schaalii is a "short bacillus, almost cocci-like" which could explain the "cocci gram +" result and consequently the choice of the gp id card.This organism should be tested with the vitek 2 anc test kit.There is no indication or report from the laboratory to biomérieux that the discrepant result led to any adverse event related to any patient's state of health.There was no patient directly associated with the eeq survey strain.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
This investigation was initiated due to a misidentification to globicatella sanguinis (96%) for a ctcb strain of actinotignum schaalii (ctcb 1811) on vitek® 2 v7.01 gp id cards.The customer strain was no longer available to submit for evaluation.Testing was performed on an internal reference strain.On vitek 2 (v7.01), tests performed from isolate subcultured on pvx with co2 atmosphere.Two lots of gp id cards were tested with the internal reference strain : customer lot 2420551103 (cl), and a random lot 2420617403 (rl) with the following results: unidentified organism with cl lot and gardnerella vaginalis (93%) with rl lot; however, the species actinotignum schaalii is not present in the gp id knowledge base (kb).Identification with vitek ms confirmed the identification to actinotignum schaalii (99.9%).There is a limitation for species not claimed in the kb : testing of unclaimed species may result in an unidentified result or a misidentification.Gp id cards perform as intended and no further action is required.

• Brand Name: VITEK®2 GP TEST KIT
• Common Device Name: VITEK®2 GP TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; saint louis MO 63042
• MDR Report Key: 7694062
• Report Number: 1950204-2018-00258
• Device Sequence Number: 995486
• Product Code: LQM
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2018

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: 05/31/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420551103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1