MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. ARTISAN LINK PRO

Model Number AR310

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

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

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

Root cause: alteration of staining in this case was due to improper operation of the air mixer.The problem was solved by field service engineer with replacement of the part.Following the replacement, the instrument was fully operational within specifications, without errors and available for the user.Failure mode description: following the air jet mixer malfunction or if the part stops working; the resulting failure modes described could occur: clogged/contaminated mixer causing uneven reagent distribution.This event can lead to a potential alteration in staining.

Event Description

Customer complaint record reported the event as follows: inconsistent staining.No direct or indirect patient harm or user harm have been reported.

• Brand Name: ARTISAN LINK PRO
• Type of Device: ARTISAN LINK PRO
• Manufacturer (Section D): AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.; no.1 yishun avenue 7; singapore north east, 76892 3; SN 768923
• Manufacturer (Section G): AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.; no.1 yishun avenue 7; singapore north east, 76892 3; SN 768923
• Manufacturer Contact: sonia siddique ; 1834 state highway 71 west; cedar creek, TX 78612 ; 5123328112
• MDR Report Key: 11097324
• MDR Text Key: 228018280
• Report Number: 3003423869-2020-00010
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 05700571108451
• UDI-Public: 5700571108451
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR310
• Device Catalogue Number: AR31030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1