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	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated calcium result generated on the alinity c processing module for a 60-year-old male patient sample.The following data was provided for one sample (customer¿s reference range 2.15-2.51 mmol/l): sample id (b)(6): (b)(6) 2026 initial result = 3.87 mmol/l, (b)(6) 2026 new sample obtained.Sample id (b)(6) result = 2.42 mmol/l, ionized calcium result = 1.27 mmol/l (normal range 1.15-1.29 mmol/l), (b)(6) 2026 new sample obtained and result with different lot = 2.39 mmol/l.The patient was admitted to the hospital for evaluation, however, no further impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a falsely elevated calcium result generated on the alinity c processing module for a 60-year-old male patient sample.The following data was provided for one sample (customer¿s reference range 2.15-2.51 mmol/l): sample id (b)(6): (b)(6) 2026 initial result = 3.87 mmol/l (b)(6) 2026 new sample obtained.Sample id (b)(6) result = 2.42 mmol/l, ionized calcium result = 1.27 mmol/l (normal range 1.15-1.29 mmol/l) (b)(6) 2026 new sample obtained and result with different lot = 2.39 mmol/l.The patient was admitted to the hospital for evaluation, however, no further impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated alinity c calcium results 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.Data and information provided by the customer were reviewed and support the complaint issue a review of tracking and trending did identify an increase in complaints for list number 07p57, however, an increase in complaint activity for lot number 77018un24 was not identified.A review of field data shows the median population result for the complaint lot is within established limits, indicating that the lot is performing acceptably in the field.A review of the device history record did not identify any nonconformances or deviations associated with the lot number and complaint issue.Labeling was reviewed and found to adequately address the issue.Based on the investigation, no systemic issue or deficiency with the alinity c calcium assay for lot 77018un24 was identified.All available patient information was included.Additional patient details are not available.

• 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: 24400211
• Report Number: 3002809144-2026-00047
• Device Sequence Number: 20866243
• Product Code: CJY
• UDI-Device Identifier: 00380740135409
• UDI-Public: (01)00380740135409(17)260309(10)77018UN24
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 04/16/2026

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: 02/11/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/16/2026
• 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: 60 YR
• Patient Sex: Male