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

Catalog Number	07P57-20
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a falsely depressed alinity c calcium result for a 58-year-old female patient.The following data was provided (customer provided reference range: 2.20 to 2.60 mmol/l): sid (b)(6): initial result = 1.01 mmol/l, repeats = 2.25 mmol/l and 2.26 mmol/l no impact to patient management was reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from the alinity c calcium, list number 07p57-20, abbott gmbh to the alinity c processing module, serial number (b)(6), list number 03r67-01, abbott laboratories.Mdr number 3016438761-2026-00064 has been submitted and all further information will be documented under that mdr number.
Event or Problem Description
The customer reported a falsely depressed alinity c calcium result for a 58 year old female patient.The following data was provided (customer provided reference range: 2.20 to 2.60 mmol/l): sid (b)(6): initial result = 1.01 mmol/l, repeats = 2.25 mmol/l and 2.26 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: 24108964
• Report Number: 3002809144-2026-00012
• Device Sequence Number: 5878796
• Product Code: CJY
• UDI-Device Identifier: 00380740132613
• UDI-Public: (01)00380740132613(17)260611(10)08921UN25
• 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): 02/05/2026

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: 06/11/2026
• Device Catalogue Number: 07P57-20
• Device Lot Number: 08921UN25
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2025
• 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: 58 YR
• Patient Sex: Female