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

Catalog Number	03L79-22
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a falsely depressed calcium result generated on the architect c16000 processing module for a 70-year-old male in-hospital patient.The following data was provided: tested on (b)(6) 2025 at 10:22 am: initial calcium result = 1.47 mmol/l (reference range: 2.10-2.55 mmol/l).The initial calcium result was reported to the clinical physician and considered the result of 1.47 to be critical and started the patient on intravenous calcium gluconate.The sample was retested for calcium on the same day, (b)(6) 2025 at 11:39 am and again at 13:21 pm generating results of 2.18 and 2.20 mmol/l which were normal.After the first repeated results were reported out, the physician discontinued the intravenous calcium gluconate treatment.The patient is doing well.There was no further impact to patient management 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.Return testing was not completed as returns were not available.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 35490un24.A review of the device history record did not identify any nonconformances or deviations associated with the complaint lot and complaint issue.The overall performance of the calcium reagents in the field was reviewed using data gathered from customers worldwide.The patient median values obtained with the complaint lot 35490un24 is within established limits, therefore the product is performing acceptably.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency of the architect calcium reagent lot 35490un24 was identified.
Event or Problem Description
The customer reported a falsely depressed calcium result generated on the architect c16000 processing module for a 70-year-old male in-hospital patient.The following data was provided: tested on (b)(6) 2025 at 10:22 am: initial calcium result = 1.47 mmol/l (reference range: 2.10-2.55 mmol/l).The initial calcium result was reported to the clinical physician and considered the result of 1.47 to be critical and started the patient on intravenous calcium gluconate.The sample was retested for calcium on the same day, (b)(6) 2025 at 11:39 am and again at 13:21 pm generating results of 2.18 and 2.20 mmol/l which were normal.After the first repeated results were reported out, the physician discontinued the intravenous calcium gluconate treatment.The patient is doing well.There was no further impact to patient management reported.

• 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: 21654751
• Report Number: 3002809144-2025-00105
• Device Sequence Number: 7535912
• Product Code: CJY
• UDI-Device Identifier: 00380740161491
• UDI-Public: (01)00380740161491(17)251008(10)35490UN24
• 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): 04/21/2025

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): Initial
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/21/2025
• 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 C16K PRC MOD, 03L77-01, (B)(6); ARC C16K PRC MOD, 03L77-01, (B)(6)
• Patient Age: 70 YR
• Patient Sex: Male