MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C8000 PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	01G06-11
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated magnesium and creatinine results generated on the architect c8000 processing module on two patients.The following results were provided: (b)(6) 2025 sid (b)(6), magnesium = 8.4 mg/dl, another instrument = 2.0 mg/dl (normal range: 1.8-2.4 mg/dl) (b)(6) 2025 sid (b)(6) creatinine = 5.15 mg/dl, another instrument = 0.86 mg/dl (normal range: 0.50-1.30 mg/dl) no impact to patient management was reported.
Additional Manufacturer Narrative
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.Section a1 patient identifier sids: (b)(6).
Event or Problem Description
The customer reported falsely elevated magnesium and creatinine results generated on the architect c8000 processing module on two patients.The following results were provided: (b)(6) 2025 sid (b)(6) magnesium = 8.4 mg/dl, another instrument = 2.0 mg/dl (normal range: 1.8-2.4 mg/dl).(b)(6) 2025 sid (b)(6) creatinine = 5.15 mg/dl, another instrument = 0.86 mg/dl (normal range: 0.50-1.30 mg/dl).No impact to patient management was reported.
Additional Manufacturer Narrative
Additional information in section d10 concomitant product.When troubleshooting the issue, the field service representative observed that the tbg., bulk 9x15 elico (rohs) was clogged/observed.Service cleaned the tbg., bulk 9x15 elicon (rohs) and deemed the part the cause for the discrepant results.Data and information provided by the customer were reviewed and support the complaint issue.A review of complaint and trending data for the architect c8000 processing module did not identify any similar issues related to the current issue.Additionally review of complaint and trending data associated with tbg., bulk 9x15 elicon (rohs) did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any non-conformances and potential non-conformances related to the current issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the architect c8000 processing module for serial number (b)(6) or the tbg., bulk 9x15 elicon (rohs) was identified.All available patient information was included.Additional patient details are not available.

• Brand Name: ARCHITECT C8000 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: 23755436
• Report Number: 3016438761-2025-00705
• Device Sequence Number: 5904338
• Product Code: JJE
• UDI-Device Identifier: 00380740000509
• UDI-Public: (01)00380740000509
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

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: 01G06-11
• 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: 11/23/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2013
• 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: CC CREATININE(1875T), 03L81-23, UNKNOWN.; CC CREATININE(1875T), 03L81-23, UNKNOWN.; CC MAGNESIUM(1000T), 03P68-22, UNKNOWN.; CC MAGNESIUM(1000T), 03P68-22, UNKNOWN.; TBG., BULK 9X15 ELICON (ROHS), 7-204380-02, UNKNOWN.
• Patient Sex: Unknown