MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 AST-P654 TEST KIT; AST-P654 TEST KIT 20 CARDS - 421912

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 (b)(6) notified biomérieux of a false positive cefoxitin screen (oxsf) result for a staphylococcus aureus strain in association with the vitek® 2 ast-p654 test kit (ref.421912, lot 8041158403).The customer stated the associated oxacillin result was susceptible, modified to resistant by aes (advanced expert system¿).Alternate methods (pcr, (b)(6) and (b)(6) screening agar ) were negative.The customer also stated that of 58 staphylococcus aureus isolates tested this week, nine (9) provided false positive oxsf results.Of the nine (9) claims, testing evidence was provided by the customer for only six (6) of the claims, including this complaint.The other five (5) are being documented in separate complaint records.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.

Manufacturer Narrative

An internal investigation was preformed following the notification of a false positive cefoxitin screen result for a patient staphylococcus aureus isolate in association with the vitek® 2 ast-p654 test kit (ref.421912, lot 8041158403).A review of complaints associated with the vitek® 2 ast-p653 lot 8041158403 did not identify a trend for this card lot.Submittal of the isolate is required in order to confirm a vitek® 2 discrepancy compared to the reference method.No investigational testing could be performed.The vitek® 20 ast-p654 lot 8041158403 met final qc release criteria.The lot passed qc performance testing for the cefoxitin screen.See section h10.

• Brand Name: VITEK® 2 AST-P654 TEST KIT
• Type of Device: AST-P654 TEST KIT 20 CARDS - 421912
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 9526925
• MDR Text Key: 219778657
• Report Number: 1950204-2019-00335
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2021
• Device Catalogue Number: 421912
• Device Lot Number: 8041158403
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1