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

Catalog Number	03L77-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete entry for section a1 - patient identifier: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.
Event or Problem Description
The customer observed falsely elevated total bilirubin results generated on the architect (b)(6) instrument for one patient.The following data was provided: (b)(6) initial total bilirubin result was 280.84 umol/l, repeated 71 umol/l.The sample was tested on mindray platform and the result was 66.0 umol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
A complaint investigation was conducted for the architect c16000, serial number (b)(6) to address the customer¿s observation of falsely elevated results.The customer service representative reviewed the instrument logs and recommended the customer wash the cuvettes with detergent a.The customer washed the cuvettes and the issue was resolved.The cuvette pair replacement set (09d33-03) was determined to be the cause of the issue.The instrument service history review revealed no additional service tickets associated with discrepant/erratic results.A review of tracking and trending did not identify any trends regarding the event.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was found to be adequate for the complaint issue.Based on our investigation, no systemic issue or deficiency was identified.
Event or Problem Description
The customer observed falsely elevated total bilirubin results generated on the architect c16000 instrument for one patient.The following data was provided: sid (b)(6) initial total bilirubin result was 280.84 umol/l, repeated 71 umol/l.The sample was tested on mindray platform and the result was 66.0 umol/l.No impact to patient management was reported.

• Brand Name: ARCHITECT C16000 PROCESSING MODULE
• Common Device Name: 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: 24775409
• Report Number: 3016438761-2026-00190
• Device Sequence Number: 6132667
• Product Code: JJE
• UDI-Device Identifier: 00380740005924
• UDI-Public: (01)00380740005924
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03L77-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NON-ABBOTT REAGENT, 01-NON ABBOTT RGT, UNKNOWN; NON-ABBOTT REAGENT, 01-NON ABBOTT RGT, UNKNOWN
• Patient Sex: Unknown