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

Catalog Number	21342
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biom¿rieux of a misidentification of staphylococcus haemolyticus as staphylococcus lentus in association with the vitek¿ 2 gram positive (gp) identification (id) test kit (ref.21342, lot 2421287103).In response to the customer complaint, a biom¿rieux field application specialist (fas) visited the customer site and confirmed the following: recommendations for isolate preparation and setup.The saline solution is sterile.The brinkmann dispensette is sterilized every other day.Biom¿rieux media are used for organism growth.The vitek 2 systems software was updated to (b)(4).The strains are pure and isolated.Therefore, the customer and fas consider that any issues with the pre-analytical phase as a root cause have been ruled out.A new vitek¿ 2 compact was installed at the customer site; however, the issues were not resolved.Electrical tests at the customer site will be conducted in order to test electrical discrepancies.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.A biom¿rieux internal investigation will be initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in colombia regarding a misidentification of staphylococcus haemolyticus as staphylococcus lentus in association with the vitek® 2 gram positive (gp) identification (id) test kit (ref.21342, lot 2421287103).The staphylococcus haemolyticus identification was obtained via vitek ms.The isolates are not available for submittal.Review of the customer's submitted lab report shows atypical positive reactions (amy, bgal, cdex, dmne, mbdg, pul, draf and sal) for an identification of staphylococcus haemolyticus according to the gp knowledge base.An increased number of atypical reactions can indicate a strain with contamination, mixed culture, use of non-recommended media or other user set up error.Without the strains or raw data, it is not possible to further evaluate the cause of the organism misidentification.Gp id lot 2421287103 met final qc release criteria.The lots passed qc performance testing.A complaint history review was completed for this issue during the last 13 month time frame 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 GP ID TEST KIT
• Common Device Name: VITEK® 2 GP ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 10006496
• Report Number: 1950204-2020-00128
• Device Sequence Number: 11543886
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 05/27/2020

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: 06/05/2021
• Device Catalogue Number: 21342
• Device Lot Number: 2421287103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2020
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 04/28/2020
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1