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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 - patient identifier, a2 - age at time of event, a3a - sex: patient 1:sample id (b)(6), 69-year-old, male.Patient 2: sample id (b)(6), 74-year-old, male.Patient 3: sample id (b)(6), 62-year-ol, female.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed discrepant results on multiple assays generated by the architect (b)(6) processing module for three patients.The initial results were not released from the laboratory.The samples were retested on another instrument, and those results were reported.The following data was provided: customer¿s reference ranges: magnesium: 1.6 to 2.6 mg/dl chloride: 101 to 110 mmol/l carbon dioxide: 22 to 29 mmol/l potassium: 3.5 to 5.0 mmol/l patient 1: sid: (b)(6) (69-year-old, male) initial magnesium result = >9.5 mg/dl, repeat results (same instrument) = 1.1 mg/dl, 2.2 mg/dl repeat results (another instrument) = 1.1 mg/dl (1:2 dilution), 2.2 mg/dl (undiluted) patient 2: sid: (b)(6) (74-year-old, male) initial magnesium result = 8.2 mg/dl, repeat result (another instrument) = 2.1 mg/dl patient 3: sid: (b)(6) (62-year-ol, female) initial chloride result = 102 mmol/l, repeat result (same instrument) = 104 mmol/l repeat chloride result (another instrument) = 129 mmol/l initial carbon dioxide result = 43 mmol/l, repeat result (another instrument) = 24 mmol/l initial potassium result = 7.1 mmol/l, repeat result (another instrument) = 4.0 mmol/l no impact to patient management was reported.
Additional Manufacturer Narrative
A complaint investigation was conducted for the architect c8000, serial number (b)(6).The field service representative (fsr) inspected the instrument determined the dirty manifold, low conc waste, lower (rohs) was determined to be the cause of the result issue.The fsr cleaned the part and the issue was resolved.The instrument service history review revealed no additional tickets associated with discrepant/erratic patient results.A review of tracking and trending did not identify any trends for the architect c8000 instrument with regards to the customer reported event.Review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency was identified.
Event or Problem Description
The customer observed discrepant results on multiple assays generated by the architect c8000 processing module for three patients.The initial results were not released from the laboratory.The samples were retested on another instrument, and those results were reported.The following data was provided: customer¿s reference ranges: magnesium: 1.6 to 2.6 mg/dl chloride: 101 to 110 mmol/l carbon dioxide: 22 to 29 mmol/l potassium: 3.5 to 5.0 mmol/l.Patient 1: sid: (b)(6) (69-year-old, male) initial magnesium result = >9.5 mg/dl, repeat results (same instrument) = 1.1 mg/dl, 2.2 mg/dl repeat results (another instrument) = 1.1 mg/dl (1:2 dilution), 2.2 mg/dl.(undiluted) patient 2: sid: (b)(6) (74-year-old, male) initial magnesium result = 8.2 mg/dl, repeat result (another instrument) = 2.1 mg/dl.Patient 3: sid: (b)(6) (62-year-ol, female) initial chloride result = 102 mmol/l, repeat result (same instrument) = 104 mmol/l, repeat chloride result (another instrument) = 129 mmol/l, initial carbon dioxide result = 43 mmol/l, repeat result (another instrument) = 24 mmol/l, initial potassium result = 7.1 mmol/l, repeat result (another instrument) = 4.0 mmol/l , no impact to patient management was reported.

• 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: 22889969
• Report Number: 3016438761-2025-00497
• Device Sequence Number: 8853344
• Product Code: JJE
• UDI-Device Identifier: 00380740000509
• UDI-Public: (01)00380740000509
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/24/2025

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: 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: 08/10/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2018
• 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 C02(7500T), 03L80-32, 67057UQ10; CC C02(7500T), 03L80-32, 67057UQ10; CC MAGNESIUM (3750T), 03P68-34, 71411UD00; CC MAGNESIUM (3750T), 03P68-34, 71411UD00; CONC ICT DILUENT, 02P32-11, 88026UN24; CONC ICT DILUENT, 02P32-11, 88026UN24
• Patient Sex: Unknown