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
An industry customer from the united states notified biomérieux of a misidentification result for the moraxella osloensis atcc 19976 strain when testing with the vitek® 2 gn id card (ref 21341).The gn card identified the sample as acinetobacter lowffii on initial testing.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was initiated following report of a us customer obtaining an excellent identification of acinetobacter lwoffii when testing moraxella osloensis atcc 19976 on vitek® 2 gn card, lot 2410611203.The customer reported no longer having the strain; therefore, the internal biomérieux strain was tested.The internal biomérieux m.Osloensis atcc 19976 strain was subbed on tsab and tested on the customer lot and a random lot of vitek 2 gn cards, in duplicate.Vitek® ms was also performed.On all four (4) cards tested, an excellent id (99%) of a.Lwoffii was obtained.Vitek ms identified the organism as m.Osloensis, with a 99.9% confidence value.A comparison of card reaction results for a.Lwoffii against expected reaction results for m.Osloensis revealed one (1) atypical positive reaction (agltp) that led to the incorrect call.Conclusion: atypical strain no further action deemed necessary.A complaint history review was completed for this issue during the last 13 month timeframe with no implication of a trend.The most recent quarterly trend review did not identify this complaint as a systemic quality issue.

• 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: 7912363
• Report Number: 1950204-2018-00393
• Device Sequence Number: 1859516
• Product Code: LQM
• UDI-Device Identifier: 03573026131913
• UDI-Public: 03573026131913
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2018

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: 07/30/2019
• Device Catalogue Number: 21341
• Device Lot Number: 2410611203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1