MAUDE Adverse Event Report: AGILENT TECHNOLOGIES, INC. ARTISAN ACID-FAST BACILLUS STAIN KIT

Model Number AR162

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

Root cause: alteration of assay and staining in this case has not been confirmed at this time.The problem has yet to be investigated by a field service engineer, and it is unknown if a field service engineer will be able to assess the complaint.This investigation thus far has yet to identify any instrument malfunction, reagent malfunction, or alteration in instrument performance.In the event that a root cause is identified, this new information will be provided via a supplemental report.Failure mode description: as no malfunction has been found as investigation is ongoing; the failure mode could not be verified as an instrument or product specific malfunction.Therefore, this report is being filed as part of agilent's commitment to due diligence reporting.

Event Description

Customer complaint record reported the event as follows:reagent packs no longer dispensing consistently.No direct or indirect patient harm or user harm have been reported.

Manufacturer Narrative

Root cause: alteration of assay and staining in this case has not been confirmed by an agilent employee.Failure mode description: customer confirmed replacement of kit resolved the issue.

Event Description

Customer complaint record reported the event as follows:reagent packs no longer dispensing consistently.No direct or indirect patient harm or user harm have been reported.

• Brand Name: ARTISAN ACID-FAST BACILLUS STAIN KIT
• Type of Device: ARTISAN ACID-FAST BACILLUS STAIN KIT
• Manufacturer (Section D): AGILENT TECHNOLOGIES, INC.; 5301 stevens creek blvd.; santa clara CA 95051
• MDR Report Key: 11286527
• MDR Text Key: 242383942
• Report Number: 2916205-2021-00001
• Device Sequence Number: 1
• Product Code: ICL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

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: No Information
• Device Model Number: AR162
• Device Catalogue Number: AR1621C-2
• Device Lot Number: 11171929
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 05/05/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1