MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C4000; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number 2P24-40

Device Problem Leak/Splash (1354)

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

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

Rcr # 3016438761-10/06/21-003-c.Further investigation determined this event was impacted by an issue identified in architect software versions 9.41 or earlier.A product correction letter was issued on 29sep2021 to all architect customer¿s notifying them of the issues in architect software versions 9.41 and earlier.The product correction letter informs the customer that an abbott representative will schedule a mandatory upgrade of their system to architect software version 9.45 or 9.5.

Event Description

The customer reported that the r1 and r2 pipettors were calibrated and error code 5667 unexpected sensor status (down activated and down ok not activated) during cuvette washer step down movement was generated on the architect c4000 analyzer.During inspection, the ambassador found that the ict aspiration 1mm syringe was lose and leaking.There was no reported impact to patient management or user safety.

• Brand Name: ARCHITECT C4000
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12819809
• MDR Text Key: 286558787
• Report Number: 3016438761-2021-00464
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00380740003753
• UDI-Public: 00380740003753
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2P24-40
• Device Catalogue Number: 02P24-40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3016438761-10/06/21-003-
• Patient Sequence Number: 1