MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. HERCEPTEST FOR AUTO LINK PLATFORMS, BR+GA; IMMUNOHISTOCHEMISTRY REAGENT

Model Number SK001

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

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

Event Date 02/02/2024

Event Type  malfunction  

Event Description

The italy customer reported that there has been a case in which they expected positive results, but the results came out negative.Customer repeated the test, and the results were positive.It was confirmed that agilent's controls showed no issues, but customer's internal controls gave inconsistent results.Investigation found the instrument to be fully functional and customer was following the correct procedure.A replacement reagent with a different lot number was provided which resolved this issue.Instrument is running and the customer was able to complete testing.No patient impact indicated.Diagnostics were not altered.There was no direct or indirect patient harm or user harm reported.

Manufacturer Narrative

No erroneous staining result was reported by the customer in connection with this incident.No patient or user harm was indicated.A1-a6: not applicable.No patient involvement.

• Brand Name: HERCEPTEST FOR AUTO LINK PLATFORMS, BR+GA
• Type of Device: IMMUNOHISTOCHEMISTRY REAGENT
• Manufacturer (Section D): AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.; no.1 yishun avenue 7; singapore north east, sgp 76892 3; SN 768923
• Manufacturer Contact: mary o'neill ; 1834 state highway 71 west; cedar creek, TX 78612 ; 3026338510
• MDR Report Key: 18781613
• MDR Text Key: 336250004
• Report Number: 3003423869-2024-00012
• Device Sequence Number: 1
• Product Code: NJT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Replace
• Type of Report: Initial
• Report Date: 02/27/2024

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: SK001
• Device Catalogue Number: SK00121-2
• Device Lot Number: 41613876
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1