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 03/11/2024

Event Type  malfunction  

Event Description

The customer reported an issue with the barcode scanner on the architect c16000 processing module.On (b)(6) 2024, the customer was reviewing patient test results and found co2 results of several samples to result as < 5.The qc was in range that day.During troubleshooting the issue, it was found that a newly added jinya afu reagent was scanned by the instrument as a co2 reagent.The customer did not release any results.The customer switch to a new jinya afu reagent and there was no scanning error.The customer retested the samples, and obtained normal co2 results.The customer did not provide additional patient information.There was no impact to patient management reported.

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 reported an issue with the barcode scanner on the architect c16000 processing module.On 11mar2024, the customer was reviewing patient test results and found co2 results of several samples to result as < 5.The qc was in range that day.During troubleshooting the issue, it was found that a newly added jinya afu reagent was scanned by the instrument as a co2 reagent.The customer did not release any results.The customer switch to a new jinya afu reagent and there was no scanning error.The customer retested the samples, and obtained normal co2 results.The customer did not provide additional patient information.There was no impact to patient management reported.

Manufacturer Narrative

Correction: updated d4 - primary udi number to (b)(4).The instrument service history review for (b)(6) revealed no additional service tickets associated with barcode reader issues or discrepant/erratic patient results.There were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.Return testing was not completed as returns were not available.A review of tracking and trending for the architect c16000 did not identify any trends.A review of tracking and trending for the barcode reader, 2d reagent, jadak 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 c16000 processing module for serial (b)(6) or the barcode reader, 2d reagent, jadak were identified.

• 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: 18944246
• MDR Text Key: 338314649
• Report Number: 3016438761-2024-00168
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00380740005924
• UDI-Public: (01)00380740005924(21)C1602171
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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
• Date Manufacturer Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BARCODE READER, 2D REAGENT, JADAK, (B)(6) ; BARCODE READER, 2D REAGENT, JADAK, (B)(6)