MAUDE Adverse Event Report: BIOMERIEUX INC. 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 in (b)(6) contacted biomérieux to report the two occurrences (two different patients) of a misidentification of staphylococcus aureus as staphylococcus lugdunensis in association with the vitek® 2 gram-positive (gp) identification (id) test kit.The isolates were obtained from vaginal swabs.The customer stated they sent the isolates to a partner laboratory for confirmatory testing.The partner lab reported identifications to staphylococcus aureus via maldi-tof method.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 due to the misidentification of two (2) patient strains of staphylococcus aureus as staphylococcus lugdunensis with the vitek® 2 v7.01 gp card.The customer submitted the two (2) patient strains (s1 and s2) for evaluation.The intended identification to s.Aureus was confirmed for both strains on vitek® ms v3 (knowledge base v3.0).On vitek 2 (v7.01) gp cards, one (1) card of the customer lot (cl : 2420628103) and one (1) card of a random lot (rl : 2420414203) were tested from cba subculture under co2 atmosphere.Both card lots gave a very good identification to s.Aureus (94%) for strain s1 and good identification to s.Aureus (91%) for strain s2.The customer misidentification to s.Lugdunensis was not reproduced in-house whatever the lot tested.The vitek 2 gp card performed as intended and no further action is required.

• Brand Name: VITEK® 2 GP ID CARD
• Type of Device: VITEK® 2 GP ID CARD
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042 ; 3147318694
• MDR Report Key: 7573813
• MDR Text Key: 110662473
• Report Number: 1950204-2018-00214
• 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: C1 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: 08/15/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2019
• Device Catalogue Number: 21342
• Device Lot Number: 2420628103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 07/19/2018
• Supplement Dates FDA Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2018
• 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