MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C16000; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number 03L77-01

Device Problem Low Test Results (2458)

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

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a1 - patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely decreased sodium results for several patients on an architect c16000 analyzer.The customer stated falsely decreased sodium results have been occurring intermittently for the past week.The results ranged from 109-114 mmol/l, when repeated were within normal range.The following examples were provided (customer¿s normal range is 136-145 mmol/l): sample id (b)(6) initial result was 111, repeat, on another analyzer, was 138 mmol/l sample id (b)(6) initial result was 113, repeat was 138 mmol/l sample id (b)(6) initial result was 113, repeat was 137 mmol/l.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for a falsely decreased sodium result on an architect c16000 processing module, serial number (b)(6) , included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Trending review determined no related trend for decreased results for the product.Return testing was not completed as returns were not available.Based on the information provided, the customer performed troubleshooting by reanalyzing the sample to obtain results within the normal range.In addition, quality control results were acceptable, indicating the assay is performing as expected.No subsequent issues have been reported.A review of the instrument history revealed no contributing factors described in this complaint.Manufacturing documentation was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency was identified.

Event Description

The customer observed falsely decreased sodium results for several patients on an architect c16000 analyzer.The customer stated falsely decreased sodium results have been occurring intermittently for the past week.The results ranged from 109-114 mmol/l, when repeated were within normal range.The following examples were provided (customer¿s normal range is 136-145 mmol/l): sample id (b)(6) initial result was 111, repeat, on another analyzer, was 138 mmol/l.Sample id (b)(6) initial result was 113, repeat was 138 mmol/l.Sample id (b)(6) initial result was 113, repeat was 137 mmol/l.There was no impact to patient management reported.

• Brand Name: ARCHITECT C16000
• 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: 18990245
• MDR Text Key: 338784130
• Report Number: 3016438761-2024-00178
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00380740005924
• UDI-Public: (01)00380740005924
• 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: 04/26/2024

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: 03L77-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1