MAUDE Adverse Event Report: AGILENT TECHNOLOGIES, INC PT LINK

Model Number PT101

Device Problems Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/02/2023

Event Type  malfunction  

Event Description

China customer reported staining alteration that was found before diagnostic results were released.Staining alteration was caused by inadequate retrieval, there was something wrong with the staining result.The pt100 could not reach the correct temperature and this issue was passed on local engineers for repair.After further investigation, it was confirmed the instrument can not be repaired; the customer will purchase another instrument.The pathologist thought that the first staining result was inconsistent with his morphological diagnosis and that this immunohistochemical result in this case should be positive, and he felt it was necessary to perform a re-staining, and then they used roche's platform to stain and got positive result.The result of the second staining obtained was indeed inconsistent with the first staining.The correct diagnosis has been released.No harm or patient impact was indicated.

Manufacturer Narrative

This malfunction may potentially impact staining performance.No erroneous staining result was reported by the customer in connection with this incident.No patient or user harm was indicated.Patient information has not been provided by the user.

Manufacturer Narrative

D3: manufacturer details were updated with correct information.Correction to manufacturer registration number, correct number is 2916205.

• Brand Name: PT LINK
• Type of Device: PT LINK
• Manufacturer (Section D): AGILENT TECHNOLOGIES, INC; 5301 stevens creek blvd; santa clara CA 95051
• Manufacturer (Section G): SHANDON DIAGNOSTICS LIMITED; tudor road; manor park; runcorn, WA7 1 TA; UK WA7 1TA
• Manufacturer Contact: mary o'neill ; 1834 state highway 71 west; cedar creek, TX 78612 ; 3026338510
• MDR Report Key: 16675696
• MDR Text Key: 313015196
• Report Number: 3003423869-2023-00044
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

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 Model Number: PT101
• Device Catalogue Number: PT10136
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1