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	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer generated false elevated alinity c calcium result on a sample that repeated lower.On (b)(6)2025, sid (b)(6) generated elevated alinity c calcium of 4.53 and 4.41 mmol/l.The sample was processed again several times using alinity and architect analyzers with values ranging from 2.02 to 2.21 mmol/l.The sample had gross haemolysis.The customer uses a calcium reference range of 2.2 to 2.6 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Section a patient information: no additional specific patient information was provided.Evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer generated false elevated alinity c calcium result on a sample that repeated lower.On (b)(6) 2025, sid (b)(6) generated elevated alinity c calcium of 4.53 and 4.41 mmol/l.The sample was processed again several times using alinity and architect analyzers with values ranging from 2.02 to 2.21 mmol/l.The sample had gross haemolysis.The customer uses a calcium reference range of 2.2 to 2.6 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Additional information: patient information section a2: age, a3: sex, a5: ethnicity and a6: race was updated.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 ticket trending review, labeling review, device history record review.Review of tracking and trending data for alinity c calcium did not identify an increase in complaints related to the complaint issue.Additionally, the similar complaint ticket search for lot 25020un24 did not identify an increase in complaint activity.Review of product labeling found adequate information regarding the issue.Device history review did not identify any non-conformances or deviations with the complaint lot and complaint issue.File sample analysis was not performed as the issue appears to be isolated to specific samples.Returns were not available.Based on the investigation, no deficiency was identified with alinity c calcium reagent lot 25020un24.
Event or Problem Description
The customer generated false elevated alinity c calcium result on a sample that repeated lower.On 10mar2025, (b)(6) generated elevated alinity c calcium of 4.53 and 4.41 mmol/l.The sample was processed again several times using alinity and architect analyzers with values ranging from 2.02 to 2.21 mmol/l.The sample had gross haemolysis.The customer uses a calcium reference range of 2.2 to 2.6 mmol/l.No impact to patient management was 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: 21671559
• Report Number: 3002809144-2025-00107
• Device Sequence Number: 11881004
• 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,Followup
• Report Date (Section B): 05/06/2025

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: 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): Initial
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 03/25/2025; 04/09/2025
• Initial Report FDA Received Date: 03/22/2025
• Supplement Report FDA Received Date: 03/31/2025; 05/06/2025
• 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, AC07323; ALNTY C PROCESSING MODU, 03R67-01, AC07323; ALNTY C PROCESSING MODU, 03R67-01, AC07323
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White