MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VITEK 2 AST-P654 TEST KIT; VITEK® 2 AST-P654 TEST KIT

Catalog Number 421912

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 germany notified biomérieux of obtaining false positive (resistant) cefoxitin screen (oxfs) results for staphylococcus aureus in association with the vitek® 2 ast-p654 test kit (ref 421912, lot 8041578403).The false positive oxfs result was not reproduced in repeat analysis.The customer stated that since the initial result was incorrect, there was a delay of >24 hours in reporting results.Initial vitek® 2: oxfs = positive (resistant).Repeat vitek® 2: oxfs = negative (susceptible).Global customer service (gcs) provided the following potential reasons for obtaining false resistant results: an inoculum that is too dense.The age of the organism is too young when inoculated into the card.The use of non-recommended media.Low level saline contamination.Use of a mixed culture.The false positive result was not reported to the physician, and there is no indication or report from the customer that this event led to any adverse event related to the patient's state of health.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

Biomerieux conducted an internal investigation in response to a customer complaint of obtaining a false positive cefoxitin screen result in association with the vitek® 2 ast-p654 test kit (ref.(b)(6) lot 8041578403) when testing a patient staphylococcus aureus isolate.The s.Aureus strain was not submitted for investigation; the customer obtained a negative cefoxitin screen result with repeat testing using lot 8041578403.A review of complaints determined there was no evidence of a trend associated with lot 8041578403.Biomerieux reviewed production and quality control records associated with lot 8041578403.There were no anomalies during the manufacturing process.Vitek® 2 ast-p654, lot 8041578403 met final qc release criteria.The root cause of the false positive cefoxitin screen result could not be determined.Submittal of the isolate is required in order to confirm a vitek® 2 discrepancy compared to the reference method.Vitek® 2 ast-p654, lot 8041578403 met final qc release criteria and there is no evidence which suggests lot 8041578403 is not performing as intended.Refer to section h10.

• Brand Name: VITEK 2 AST-P654 TEST KIT
• Type of Device: VITEK® 2 AST-P654 TEST KIT
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 11279274
• MDR Text Key: 258589106
• Report Number: 1950204-2021-00014
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• PMA/PMN Number: K053097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2022
• Device Catalogue Number: 421912
• Device Lot Number: 8041578403
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1