MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT; VITEK® 2 GP ID CARD

Catalog Number	21342
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 the united states contacted biomérieux to report the occurrence of a misidentification of cap survey enterococcus faecium ((b)(4)) as enterococcus gallinarum in association with the vitek® 2 gram positive (gp) identification (id) test kit.There is no indication or report from the laboratory or a physician that the discrepant result led to any adverse event related to any patient's state of health.There was no patient directly associated with the cap survey strain.Biomérieux requested strain submittal from the customer; however, the strain is no longer available.A biomérieux internal investigation has been initiated and will use biomérieux's internal cap survey strain.
Additional Manufacturer Narrative
An internal biomérieux investigation was initiated due to a misidentification of cap survey enterococcus faecium (cap d-b 2018, d-11) as enterococcus gallinarum in association with the vitek® 2 gram positive (gp) identification (id) test kit.The customer strain was not available for submittal nor was the initial vitek 2 lab report showing the misidentification; therefore, the internal biomérieux cap strain was tested.Sample 911778 (biomerieux cap strain d-b 2018, d-11 strain): all four (4) vitek gp id cards tested resulted in a very good identification of enterococcus faecium.Vitek® ms gave a confirmatory identification of enterococcus faecium at 99.9%.As enterococcus faecium was the intended result, the customer's discrepancy was not reproduced and the vitek 2 cards are performing as expected.Without the customer's lab report showing the misidentification, it was not possible to examine the biochemical reactions to determine possible causes for the discrepancy.

• Brand Name: VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT
• Common Device Name: VITEK® 2 GP ID CARD
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; st. louis MO 63042
• MDR Report Key: 7966951
• Report Number: 1950204-2018-00432
• Device Sequence Number: 13811471
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/26/2018

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: 06/03/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420554103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1