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

Catalog Number 02P24-40

Device Problem Low Test Results (2458)

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

Event Date 04/11/2024

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information has been included.No additional patient details are available.

Event Description

The customer observed falsely depressed sodium results generated on the architect c4000 instrument for one patient.The following data was provided: on (b)(6) 2024 at 1:15am initial result for sid (b)(6) was 119 mmol/l, rerun result 133 mmol/l.Second draw when patient came in to er drawn on (b)() 2024 at 3:45am sid (b)(6) was 133 mmol/l, rerun result 135 mmol/l (normal range 133 - 142 mmol/l).Patient historical na results 133 - 135 mmol/l.No impact to patient management was reported.

Manufacturer Narrative

The aero c8k ict mod was determined to be the cause of the depressed result.The customer replaced the part, and the issue was resolved.No additional discrepant result issues have been reported since the part was replaced.The instrument service history review revealed no additional service tickets associated with discrepant/erratic results.Trending review did not identify any trends.Additionally, labeling was reviewed and adequately addressed the issue under review.Based on the investigation, no deficiency was identified.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 19214758
• MDR Text Key: 341491173
• Report Number: 3016438761-2024-00249
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00380740003753
• UDI-Public: (01)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
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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 Catalogue Number: 02P24-40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 05/21/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1