MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CALCIUM REAGENT KIT; AZO DYE, CALCIUM

Catalog Number	07P57-20
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
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 observed a falsely decreased alinity c calcium result for one patient.The following data was provided (customer¿s normal range is 8.4-10.2 mg/dl): sample id (b)(6) initial result, on (b)(6) 2025, was 4.6, repeat result was 8.8 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for a falsely decreased alinity c calcium result included a review of data provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.A review of tracking and trending for the product and the likely cause lot did not identify an increase in complaint activity.Device history record review did not show any potential non-conformances or deviations.The customer retested the sample with the same reagent and result was normal.Quality controls were in range at the time of the discrepant result, indicating the assay is performing as expected.The customer advised that the sample was hemolyzed.Labeling was reviewed and found to adequately address the issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency for alinity c calcium reagent lot number 00145un25, was identified.
Event or Problem Description
The customer observed a falsely decreased alinity c calcium result for one patient.The following data was provided (customer¿s normal range is 8.4-10.2 mg/dl): sample id (b)(6), initial result, on (b)(6) 2025, was 4.6, repeat result was 8.8 mg/dl.There was no impact to patient management reported.

• Brand Name: ALINITY C CALCIUM REAGENT KIT
• 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: 22099450
• Report Number: 3002809144-2025-00169
• Device Sequence Number: 7425038
• Product Code: CJY
• UDI-Device Identifier: 00380740132613
• UDI-Public: (01)00380740132613(17)260409(10)00145UN25
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 08/06/2025

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: 04/09/2026
• Device Catalogue Number: 07P57-20
• Device Lot Number: 00145UN25
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• 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: ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Sex: Unknown