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	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated results for multiple assays generated on the architect c16000 processing module for multiple samples.The following results were provided: sid: (b)(6): total bilirubin initial result = 20.593 umol/l, repeat result = 10.661 umol/l.Calcium initial result = 3.6752 mmol/l, repeat result = 2.3521 mmol/l.Glucose initial result = 8.793 mmol/l (161.6576 mg/dl), repeat result = 4.568 mmol/l (82.2971 mg/dl).Potassium initial result = 8.444 mmol/l, repeat result = 4.3 mmol/l.Sid (b)(6): potassium initial result = 6.775 mmol/l, repeat result = 3.772 mmol/l.Glucose initial result = 9.887 mmol/l (178.1242), repeat result = 4.671 mmol/l (84.1527 mg/dl).Sid:(b)(6): potassium initial result = 7.250 mmol/l, repeat result = 3.933 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Section a1 patient identifier complete information:(b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated results for multiple assays generated on the architect c16000 processing module for multiple samples.The following results were provided: sid: (b)(6): total bilirubin initial result = 20.593 umol/l, repeat result = 10.661 umol/l.Calcium initial result = 3.6752 mmol/l, repeat result = 2.3521 mmol/l.Glucose initial result = 8.793 mmol/l (161.6576 mg/dl), repeat result = 4.568 mmol/l (82.2971 mg/dl).Potassium initial result = 8.444 mmol/l, repeat result = 4.3 mmol/l.Sid (b)(6): potassium initial result = 6.775 mmol/l, repeat result = 3.772 mmol/l.Glucose initial result = 9.887 mmol/l (178.1242), repeat result = 4.671 mmol/l (84.1527 mg/dl).Sid: (b)(6): potassium initial result = 7.250 mmol/l, repeat result = 3.933 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the architect c16000 processing module and observed a loose r1a probe.The fsr resolved the issue by tightening and calibrating the reagent probe (l), which contributed to the result issue.The instrument service history review revealed no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.Data and information provided by the customer were reviewed and support the complaint issue.A review of complaint and trending data for the architect c16000 processing module did not identify any similar issues related to the with regards to the current issue.Additionally review of complaint and trending data associated with the reagent probe (l) did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any non-conformances or potential non-conformances for the reagent probe (l) and the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the architect c16000 processing module for serial number (b)(6) was identified.All available patient information was included.Additional patient details are not available.

• 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: 22750087
• Report Number: 3016438761-2025-00465
• Device Sequence Number: 9558039
• Product Code: JJE
• UDI-Device Identifier: 00380740005924
• UDI-Public: (01)00380740005924
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 08/20/2025

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: 07/31/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2008
• 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: AERO RGT PRB (L), 09D48-02, UNKNOWN.; AERO RGT PRB (L), 09D48-02, UNKNOWN.
• Patient Sex: Unknown