MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT CALCIUM; AZO DYE, CALCIUM

Catalog Number	03L79-32
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed calcium results generated on the architect c8000 processing module for a 57-year-old male patient.The following results were provided: (customer provided patient normal range: 8.4-10.5 mg/dl, patient critical low= <6.0 mg/dl, patient critical high= >13.0 mg/dl) (b)(6) 2025 sid (b)(6) initial result = 5.9 mg/dl, the emergency room drew another sample shortly after as a point of care and they got a normal result.(no specific result provided) (b)(6) 2025 repeat result of same sample on another architect (b)(6) = 9.6 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.
Additional Manufacturer Narrative
The complaint investigation for false depressed architect calcium results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Review of tracking and trending for the architect calcium assay did not identify an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 27341un25.The device history record review did not show any nonconformances, potential nonconformances or deviations associated with the lot number.The overall performance of architect calcium reagent in the field was reviewed using data from customers worldwide.A review of assay field performance data indicates that the patient median is within the established limits for lot 27341un25.Labeling was reviewed and found to adequately address the issue.Based on the investigation, no systemic issue or deficiency of the architect calcium assay for lot 27341un25 was identified.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely depressed calcium results generated on the architect c8000 processing module for a 57-year-old male patient.The following results were provided: (customer provided patient normal range: 8.4-10.5 mg/dl, patient critical low= <6.0 mg/dl, patient critical high= >13.0 mg/dl) on (b)(6) 2025 sid (b)(6) initial result = 5.9 mg/dl, the emergency room drew another sample shortly after as a point of care and they got a normal result.(no specific result provided) on (b)(6) 2025 repeat result of same sample on another architect (b)(6) = 9.6 mg/dl no impact to patient management was reported.

• Brand Name: ARCHITECT CALCIUM
• Common Device Name: AZO DYE, CALCIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 23716474
• Report Number: 3002809144-2025-00383
• Device Sequence Number: 12973117
• Product Code: CJY
• UDI-Device Identifier: 00380740161507
• UDI-Public: (01)00380740161507(17)260708(10)27341UN25
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K062855
• 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): 02/04/2026

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 Expiration Date: 07/08/2026
• Device Catalogue Number: 03L79-32
• Device Lot Number: 27341UN25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2025
• 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: ARC C8 PROC MOD, 01G06-11, (B)(6); ARC C8 PROC MOD, 01G06-11, (B)(6).
• Patient Age: 57 YR
• Patient Sex: Male