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 shigella sonnei (neqas distribution 4486, specimen 5012) as pluralibacter gergoviae in association with the vitek® 2 gram negative (gn) identification (id) test kit.The identification to shigella sonnei was confirmed via vitek ms testing followed by shigella latex.There was no gn id repeat testing for this neqas strain.The customer stated that there was no adverse impact to any patient's state of health; the neqas strain was not directly associated with any patient.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed for a misidentification of shigella sonnei (neqas distribution 4486, specimen 5012) as pluralibacter gergoviae in association with the vitek® 2 gram negative (gn) identification (id) test kit.The submitted strain was subcultured to cba agar (cos biomerieux) and testing included vitek 2 gn cards from the customer's lot (2410734103) and a random lot (2410833203), as well as api® 20e strip.The gn id cards gave an excellent identification to shigella sonnei (99%) on both lots tested.The api 20e strip gave a very good identification to shigella sonnei (99.1%).Examination of the customer's biochemical reactions from their submitted misidentification lab report showed one discrepant positive urea reaction in comparison to the gn id card's knowledge base for shigella sonnei.An increased number of atypical reactions can indicate contamination, mixed culture, use of non-recommended media or other user set up error.Conclusion : in-house, the customer misidentification to pluralibacter gergoviae is not reproduced and the correct identification to shigella sonnei, expected by the neqas, is obtained whatever the product tested.Vitek 2 gn lot #2410734103 met final qc release criteria and 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: 8745175
• Report Number: 1950204-2019-00219
• Device Sequence Number: 11135248
• 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): 09/19/2019

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: 08/27/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1