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

Catalog Number 21342

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer from (b)(6) contacted biomérieux to report the occurrence of a misidentification of staphylococcus aureus as staphylococcus lugdunensis in association with the vitek® 2 gp id test kit (lot 2420500403).The strain was twice identified as staphylococcus lugdunensis with the gp id card.The staphylococcus aureus identification was confirmed by maldi-tof.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 has been initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: no testing set up information was provided.Four (4) laboratory reports were received with three (3) reports showing an excellent identification of s.Lugdenensis and one (1) with a very good identification of s.Lugdenensis.Two (2) laboratory reports showed two (2) atypical negative reactions (aglu, phos) and two (2) laboratory reports showed five (5) (mostly negative) atypical reactions (negative: aglu, phos, dmal, dman & positive: sac) for an identification of s.Aureus according to the gp knowledge base.An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain.Without the strain or raw data it's not possible to further evaluate the cause of the misidentification.Gp lot # 2420488103 and 2420500403 met final qc release criteria.These lots passed initial qc performance testing.

• Brand Name: VITEK® 2 GRAM-POSITIVE (GP) IDENTIFICATION (ID) TEST KIT
• Type of Device: VITEK® 2 GP ID CARD
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 7398927
• MDR Text Key: 105183983
• Report Number: 1950204-2018-00133
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: CL. I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420500403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1