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	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow 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 reported a falsely elevated calcium result generated on the alinity c processing module on a patient.Results provided: sid (b)(6).Sn# (b)(6) = 9.52 / 13.62 mg / dl with reagent 88813un24.Sn# (b)(6) = 16.15 with reagent 66462un24.Sn# (b)(6) = 17.09 / 11.9 with reagent 88813un24.Reference range: 8.4 to 10.2 mg/dl.No impact to patient management was reported.
Event or Problem Description
The customer reported a falsely elevated calcium result generated on the alinity c processing module on a patient.Results provided:(b)(6).Sn# (b)(6) = 9.52 / 13.62 mg / dl with reagent 88813un24.Sn# (b)(6) = 16.15 with reagent 66462un24.Sn# (b)(6) = 17.09 / 11.9 with reagent 88813un24.Reference range: 8.4 to 10.2 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
A ticket search by the lot number 88813un24 did identify an increase in complaint activity related to the issue under review.However, the trend review by product list number ln 07p57 found no trends related to this issue.Manufacturing documentation for the likely cause did not identify any issues associated with the complaint issue.As part of troubleshooting samples were rerun, and quality control results were within range.Based on the complaint investigation, no product deficiency of the alinity c calcium assay (ln 07p57-30) lot 88813un24 was identified.

• 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: 21420262
• Report Number: 3002809144-2025-00046
• Device Sequence Number: 7764219
• Product Code: CJY
• UDI-Device Identifier: 00380740135409
• UDI-Public: (01)00380740135409(17)250626(10)88813UN24
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 03/19/2025

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: 06/26/2025
• Device Catalogue Number: 07P57-30
• Device Lot Number: 88813UN24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• 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 PROC MOD, 03R67-01, AC06919,AC03870,AC0328; ALNTY C PROC MOD, 03R67-01, AC06919,AC03870,AC0328
• Patient Sex: Unknown