MAUDE Adverse Event Report: BIOMERIEUX, INC. 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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from (b)(6) contacted biomérieux to report a misidentification of a listeria monocytogenes strain in association with the vitek® 2 gram-positive (gp) identification (id) card.The customer did not provide the organism species to which the gp id card made the identification, nor provide information regarding any alternate method used to obtain the correct identification of listeria monocytogenes.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to the patient's state of health.Biomérieux requested strain submittal from the customer.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed for a misidentification of listeria monocytogenes as several other listeria species or unidentified when tested with the vitek® 2gram-positive (gp) identification (id) card (lot 2420575103) using vitek 2 software version 7.01.The strain was identified as l.Monocytogenes by api, pcr and maldi-tof.Investigation: no set up information was provided.It's not clear if the testing involved one isolate or several.It was noted that the customer had received a new lot of gp cards from a new supplier and experienced issues.However the customer did not perform qc on the new lot of cards from the new supplier.Eight lab reports were submitted.One lab report showed a low discrimination result between l.Monocytogenes and l.Welshimeri.This is considered a correct result.Two lab reports showed an unidentified organism result with five atypical positive reactions (dxyl, dsor, llatk, dman, dgal) for an identification of l.Monocytogenes according to the gp knowledge base.Four lab reports showed an identification of l.Welshimeri.Two lab reports showed one atypical positive reaction (dxyl) and two lab reports showed three atypical reactions (dxyl+, aglu-, dgal+) for an identification of l.Monocytogenes according to the gp knowledge base.One lab report showed an identification of l.Grayii with three atypical positive reactions (dsor, dgal, dman) for an identification of l.Monocytogenes according to the gp knowledge base.Atypical positive reactions can indicate contamination, mixed culture, use of non recommended media or other user set up errors or an atypical strain.However without the strain or raw data it's not possible to further evaluate the cause of the misidentification.The vitek 2 gp lot #2420575103 met final qc release criteria.This lot passed qc performance testing.

• Brand Name: VITEK® 2 GP ID CARD
• Common Device Name: VITEK® 2 GP ID CARD
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 7932468
• Report Number: 1950204-2018-00411
• Device Sequence Number: 19400385
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/17/2018

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: 06/24/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420575103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1