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

Catalog Number	03L79-32
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated calcium results generated on the architect c16000 processing module for one patient.The following results were provided: initial result 3.53 mmol/l, repeated 2.21 mmol/l, a new sample was obtained the next day and the result was 2.19 mml/l.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation 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 and the complaint lot did not identify an increase in complaint activity related to the issue under review.Manufacturing documentation for the likely cause did not identify any issues associated with the complaint issue.Field data review suggest the product is performing acceptably in the field.Review of product labeling found adequate information regarding the issue under review.As part of troubleshooting samples were rerun, and the data suggests the product is performing acceptably.Based on the complaint investigation, no product deficiency of the architect calcium assay (ln 03l79-32) lot 02176un24 was identified.
Event or Problem Description
The customer observed falsely elevated calcium results generated on the architect c16000 processing module for one patient.The following results were provided: initial result 3.53 mmol/l, repeated 2.21 mmol/l, a new sample was obtained the next day and the result was 2.19 mml/l.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: 22675417
• Report Number: 3002809144-2025-00250
• Device Sequence Number: 21194163
• Product Code: CJY
• UDI-Device Identifier: 00380740161507
• UDI-Public: (01)00380740161507(17)250820(10)02176UN24
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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 Expiration Date: 08/20/2025
• Device Catalogue Number: 03L79-32
• Device Lot Number: 02176UN24
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2024
• 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 C16K PRC MOD, 03L77-01, C1601512; ARC C16K PRC MOD, 03L77-01, C1601512
• Patient Sex: Unknown