MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 GRAM NEGATIVE IDENTIFICATION TEST KIT; VITEK® 2 GN ID TEST KIT

Catalog Number	21341
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 biomérieux of a misidentification of a shigella sonnei patient train as pluralibacter gergoviae in association with the vitek® 2 gram negative (gn) identification (id) test kit.Repeat testing obtained the same result.The identification to shigella sonnei was confirmed via vitek ms testing followed by shigella latex.The customer stated that the discrepant gn id result was not reported to the treating physician, and there was no adverse impact to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An investigation was completed in response to a customer complaint of a misidentification of a shigella sonnei patient strain as pluralibacter gergoviae in association with the vitek® 2 gram negative (gn) identification (id) test kit.Repeat testing obtained the same result.The customer submitted the strain for investigational testing.Identification testing was performed with the vitek® gn id test kit from the customer's lot (2410734103) and a random lot (2410984203) in duplicate.An api® 20e rapid test kit was also used as an alternative identification method.All results obtained with the vitek® 2 gn id test kit cards from both the customer lot and the random lot were excellent identifications of shigella sonnei.The api® 20e rapid test kit also obtained an identification of shigella sonnei.Review of the customer's identification of pluralibacter gergoviae revealed one atypical positive reaction (ure) for an identification of shigella sonnei according to the knowledge base.Atypical positive reactions can indicate contamination, mixed culture, use of non-recommended media, or other user set up error.The customer's misidentification was not reproduced internally.The vitek® 2 gn id test kit cards are performing as expected.Gn lot #2410734103 met final qc release criteria.This lot passed qc performance testing.

• Brand Name: VITEK® 2 GRAM NEGATIVE IDENTIFICATION TEST KIT
• Common Device Name: VITEK® 2 GN ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• MDR Report Key: 8745173
• Report Number: 1950204-2019-00220
• Device Sequence Number: 1330193
• Product Code: LQM
• UDI-Device Identifier: 03573026131913
• UDI-Public: 03573026131913
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 11/05/2019

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: 11/30/2019
• Device Catalogue Number: 21341
• Device Lot Number: 2410734103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1