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	11/19/2025
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 falsely elevated calcium results generated from alinity c processing module for a 5-month-old female patient.Results were reported to medical provider.The following data was provided.On (b)(6) 2025, sid: (b)(6), initial result on this analyzer = 3.86 mmol/l, repeat results =3.10 mmol/l.On (b)(6) 2025, sid: (b)(6); (b)(6), results were 3.17 mmol/l & 3.26 mmol/l with cntl flag, and repeat results were 2.35 mmol/l & 2.34 mmol/l.On (b)(6) 2025, sid: (b)(6); (b)(6), results were 2.16 mmol/l & 2.14 mmol/l, on (b)(6) 2025, sid: (b)(6); (b)(6), results were 3.86 mmol/l, 3.01 mmol/l, 2.14 mmol/l, 2.16 mmol/l, on (b)(6) 2025, sid: (b)(6); (b)(6), results were 2.05 mmol/l, 2.05 mmol/l.The customer uses reference range for normal: 2.1 - 2.55 mmol/l& abnormal 1.5 - 3.0 mmol/l.There was no reported impact to patient management.
Additional Manufacturer Narrative
Updated b3 - date of event from 11/21/2025 to 11/19/2025.Data and information provided by the customer were reviewed and support the complaint issue.Review of tracking and trending for the alinity c calcium assay did identify an increase in complaint activity related to the complaint issue.However, no trends were identified for lot 77018un24.A device history record review did not identify any nonconformances or deviations associated with the complaint lot number and complaint issue.Labeling was reviewed which adequately addresses the current issue.Based on our investigation, no systemic issue or deficiency with the alinity c calcium reagent for lot 77018un24 was identified.
Event or Problem Description
The customer observed falsely elevated calcium results generated from alinity c processing module for a 5-month-old female patient.Results were reported to medical provider.The following data was provided.(b)(6) 2025, sid (b)(6), initial result on this analyzer = 3.86 mmol/l, repeat results =3.10 mmol/l (b)(6) 2025, sid (b)(6); (b)(6), results were 3.17 mmol/l & 3.26 mmol/l with cntl flag, and repeat results were 2.35 mmol/l & 2.34 mmol/l.(b)(6) 2025, sid (b)(6); (b)(6), results were 2.16 mmol/l & 2.14 mmol/l,(b)(6) 2025, sid (b)(6); (b)(6), results were 3.86 mmol/l, 3.01 mmol/l, 2.14 mmol/l, 2.16 mmol/l, (b)(6) 2025, sid (b)(6); (b)(6), results were 2.05 mmol/l, 2.05 mmol/l.The customer uses reference range for normal: 2.1 - 2.55 mmol/l& abnormal 1.5 - 3.0 mmol/l.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: 23687652
• Report Number: 3002809144-2025-00378
• Device Sequence Number: 13118953
• Product Code: CJY
• UDI-Device Identifier: 00380740135409
• UDI-Public: (01)00380740135409(17)260309(10)77018UN24
• 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): 02/04/2026

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: 03/09/2026
• Device Catalogue Number: 07P57-30
• Device Lot Number: 77018UN24
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2025
• 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 Age: 5 MO
• Patient Sex: Female