MAUDE Adverse Event Report: Abbott Ireland Diagnostics Division Alinity c Creatinine2; alkaline picrate, colorimetry, creatinine

Catalog Number	04T91-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a falsely elevated alinity c creatinine2 result generated on the alinity c processing module.The questioned creatinine result did not match previous results, and the patient was admitted to the hospital.The following data was provided: (b)(6)2026, sid (b)(6): initial creatinine2 result = 2.37 mg/dl (normal range: 0.72 to 1.25 mg/dl) (b)(6)2026, repeat creatinine2 result = 0.70 mg/dl (measured from original sample stored in the refrigerator) there was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up 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.

• Brand Name: Alinity c Creatinine2
• Common Device Name: alkaline picrate, colorimetry, creatinine
• Manufacturer (Section D): Abbott Ireland Diagnostics Division; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): Abbott Ireland Diagnostics Division; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; +49()6122582960
• MDR Report Key: 50771439
• Report Number: 3005094123-2026-00458
• Device Sequence Number: 18781975
• Product Code: CGX
• UDI-Device Identifier: 00380740159528
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K210452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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 Catalogue Number: 04T91-20
• Device Lot Number: 89446UD00
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2026
• 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)
• Patient Sex: Unknown