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 Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from the united states reported a misidentification of staphylococcus aureus patient strain (wound culture) as staphylococcus pseudintermedius in association with the vitek® 2 gp test kit (lot 2420614403).The customer obtained the identification of s.Pseudintermedius using the gp card and their latex test was positive.Alternate testing was done by an external lab that tested the strain by vitek 2, vitek ms, and microscan in which all methods identified the organism as s.Aureus.The customer reported that to their knowledge there was no delay, there was no unnecessary patient treatment or procedures and no notification from a physician about the result(s).There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A customer from the united states reported a misidentification of staphylococcus aureus patient strain (wound culture) as staphylococcus pseudintermedius in association with the vitek® 2 gp test kit (lot 2420614403).An internal biomérieux investigation was performed.The us customer submitted two (2) gram positive organisms for vitek 2 evaluation because the gp card identified both as s.Pseudintermedius.Vitek® ms identified both as s.Aureus.Both organisms were subbed and tested on the customer lot and a random lot of vitek 2 gp cards, in duplicate.Vitek ms was also performed.911635 (4911541): an excellent id (96%) of s.Aureus was obtained on one (1) of the cards from the customer lot.A low discrimination call of s.Aureus/s.Lugdunensis/s.Pseudintermedius was obtained on one (1) card from the customer lot and on the two (2) cards from the random lot.Vitek ms identified the organism as s.Aureus with a 99.9% confidence value.Since s.Aureus is part of the low discrimination call, all four (4) cards tested gave the correct identification of s.Aureus.911636 (4918806): on all four (4) cards tested, an excellent id (99%) of s.Aureus was obtained.Vitek ms also identified the organism as s.Aureus, with a 99.9% confidence value.A comparison of customer card reaction results for s.Pseudintermedius against expected reaction results for s.Aureus revealed one (1) atypical negative reaction (aglu) and one (1) atypical positive reaction (leua) that led to the incorrect call.An increased number of atypical reactions can indicate contamination, mixed culture, use of non-recommended media, user set up error, or an atypical strain.Vitek 2 gp cards are performing as expected and no further action is necessary.

• 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: 7675818
• Report Number: 1950204-2018-00248
• Device Sequence Number: 11151598
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2018

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: 08/02/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420614403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1