MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C8000; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number 01G06-11

Device Problems Thermal Decomposition of Device (1071); Leak/Splash (1354)

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

Event Date 01/29/2024

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed multiple instrument error codes being generated on the architect c8000 processing module.The field service engineer (fse) arrived at the customer¿s facility to inspect the instrument and resolve the instrument error codes that were generated.The fse was onsite every day during the week of (b)(6)troubleshooting and resolving the multiple instrument error codes that were generated on the architect c8000 processing module.On (b)(6) 2024, the customer was getting detergent up sensor error when using the architect c8000 processing module.The sensor is staying on when not activated.The field service engineer (fse) arrived onsite to troubleshoot the error when it was discovered the cn8 cable that goes to the cnn board was charred at the point above the cuvette washer pump.On (b)(6) 2024, upon review of the error log of the instrument, the result of the charred cn8 cable was due to a leak.The leak seeped down the ict asp sensor cable to the connection on the pump and corroded the connections and eventually charred the cable causing the wash solution pump errors.There was no harm or injury reported.There was no further impact to patient management or user safety reported.

Event Description

The customer observed multiple instrument error codes being generated on the architect c8000 processing module.The field service engineer (fse) arrived at the customer¿s facility to inspect the instrument and resolve the instrument error codes that were generated.The fse was onsite every day during the week of (b)(6) troubleshooting and resolving the multiple instrument error codes that were generated on the architect c8000 processing module.On (b)(6) 2024, the customer was getting detergent up sensor error when using the architect c8000 processing module.The sensor is staying on when not activated.The field service engineer (fse) arrived onsite to troubleshoot the error when it was discovered the cn8 cable that goes to the cnn board was charred at the point above the cuvette washer pump.On (b)(6) 2024, upon review of the error log of the instrument, the result of the charred cn8 cable was due to a leak.The leak seeped down the ict asp sensor cable to the connection on the pump and corroded the connections and eventually charred the cable causing the wash solution pump errors.There was no harm or injury reported.There was no further impact to patient management or user safety reported.

Manufacturer Narrative

The field service representative (fsr) inspected the instrument and discovered the cable, cnn8-pump sensors was charred/burned due to the tbg, ict 1ml syr-hc t fitting (rohs) leaking as the part was clogged.The fsr cleaned and retightened the tbg, ict 1ml syr-hc t fitting (rohs) and replaced the cable, cnn8-pump sensors, which resolved the issue.Return testing was not completed as returns were not available.The instrument service history review for (b)(6) verifies no subsequent issues have been reported related to charred/burned parts after service intervention.A review of tracking and trending for the architect c8000 did not identify any trends.A review of tracking and trending for the tbg, ict 1ml syr-hc t fitting (rohs) and the cable, cnn8-pump sensors did not identify any trends.Review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect c8000 for serial (b)(6) or the tbg, ict 1ml syr-hc t fitting (rohs) and the cable, cnn8-pump sensors were identified.

• Brand Name: ARCHITECT C8000
• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18717285
• MDR Text Key: 335520652
• Report Number: 3016438761-2024-00088
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00380740000509
• UDI-Public: 00380740000509
• 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
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01G06-11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1