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

Catalog Number	07P57-30
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated calcium generated from alinity c processing module.The customer compared results with other analyzers, including the architect platform and provided the following data: customer reference range for adjusted calcium is 2.2-2.6mmol/l.Customer reference range for calcium is 1.75-3mmol/l.Sample id (b)(6).Results on alinity were 3.04 (on sn: (b)(6), 4.78 (on sn:(b)(6), & 4.30 mmol/l (on sn: (b)(6).Result on architect were 2.12 & 2.49 mmol/l.Per the customer discrepant results were not reported out to the medical provider.There was no reported impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, a review of tracking and trending, labeling review, and device history record 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 alinity c 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 complaint lot.Device history record review did not identify any nonconformances or deviations with complaint lot and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Based on our investigation, no systemic issue or deficiency with the alinity c calcium reagent lot 25020un24 was identified.
Event or Problem Description
The customer observed falsely elevated calcium generated from alinity c processing module.The customer compared results with other analyzers, including the architect platform and provided the following data: customer reference range for adjusted calcium is 2.2-2.6mmol/l.Customer reference range for calcium is 1.75-3mmol/l.Sample id (b)(6).Results on alinity were 3.04 (on sn: (b)(6), 4.78 (on sn: (b)(6), & 4.30 mmol/l (on sn: (b)(6).Result on architect were 2.12 & 2.49 mmol/l.Per the customer discrepant results were not reported out to the medical provider.There was no reported impact to patient management.

• 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: 21906149
• Report Number: 3002809144-2025-00143
• Device Sequence Number: 8728471
• Product Code: CJY
• UDI-Device Identifier: 00380740135409
• UDI-Public: (01)00380740135409(17)251008(10)25020UN24
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/10/2025

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: 07P57-30
• Device Lot Number: 25020UN24
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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: ALNTY C PROCESSING MODU, 03R67-01, (B)(6),; ALNTY C PROCESSING MODU, 03R67-01, (B)(6),; ALNTY C PROCESSING MODU, 03R67-01, (B)(6),; ALNTY C PROCESSING MODU, 03R67-01, (B)(6).
• Patient Sex: Unknown