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

Catalog Number	03L79-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
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 result generated by the architect c4000 processing module for a patient.The same sample was repeated, and a lower result was obtained.The following data was provided: sid (b)(6): initial calcium result = 15.40 mg/dl; repeat result = 9.29 mg/dl.Per the calcium reagent package insert, the reference range for adult is 8.4 to 10.2 mg/dl.There was no impact to patient management reported.
Event or Problem Description
The customer observed falsely elevated calcium result generated by the architect c4000 processing module for a patient.The same sample was repeated, and a lower result was obtained.The following data was provided: sid (b)(4): initial calcium result = 15.40 mg/dl; repeat result = 9.29 mg/dl.Per the calcium reagent package insert, the reference range for adult is 8.4 to 10.2 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, a ticket trending review, a device history record review, and a labeling review.Return testing was not completed as returns were not available.The data and information provided by the customer were reviewed and support the complaint issue.A review of tracking and trending for the 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 35490un24.A review of the device history record did not identify any non-conformances or deviations with lot 35490un24 and the complaint issue.A review of labeling was performed and found to sufficiently address the customer's issue.Based on this investigation, no systemic issue or deficiency was identified with the calcium reagent, lot number 35490un24.

• Brand Name: 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: 22201298
• Report Number: 3002809144-2025-00186
• Device Sequence Number: 7723454
• Product Code: CJY
• UDI-Device Identifier: 00380740161491
• UDI-Public: (01)00380740161491(17)251008(10)35490UN24
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K062855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: 10/08/2025
• Device Catalogue Number: 03L79-22
• Device Lot Number: 35490UN24
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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 C4000 INTGR, 02P24-40, (B)(6).; ARC C4000 INTGR, 02P24-40, (B)(6).
• Patient Sex: Unknown