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	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete entry for section a1 - patient identifier: (b)(6).Complete entry for sections a2 - age at time of event, a2 - age units (patient) and a3a - sex: 66, year, female; 59, year, male; 41, year, female.An evaluation is in process.A follow-up 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 observed falsely elevated creatinine2 on the alinity c processing module for multiple patients.The following results were provided (reference range 0.50 ¿ 1.40 mg/dl): on (b)(6) 2025, sid (b)(6), 66-year-old female, initial creatinine result= 2.58 mg/dl; repeat result= 0.57 mg/dl.On (b)(6) 2025, sid (b)(6), 59-year-old male, initial creatinine result= 3.47 mg/dl; repeat result= 0.83 mg/dl.On (b)(6) 2025, sid (b)(6), 41-year-old female, initial creatinine result= 5.39 mg/dl; repeat result= 1.35 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
Updated entry for section a1 - patient identifier: (b)(6).Complete entry for sections a2 - age at time of event, a2 - age units (patient) and a3a - sex: 66, year, female; 59, year, male; 41, year, female; 55, year, male; 79, year, female; 64, year, female; 47, year, female; 73, year, female; 81, year, male; 66, year, female; 33, year, male; 71, year, female; 71, year, female; 74, year, male; 34, year, male; 76, year, male; 82, year, female; 75, year, male.Update to section b5 - describe event or problem to include additional patient results.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Review of tracking and trending for the creatinine2 assay did not identify any trends related to the complaint issue.Additionally, no trends were identified for lot 76220ud00.A device history record review did not identify any non-conformances or deviations with lot number 76220ud00 and the complaint issue.In-house specificity testing of a retained kit of the complaint lot was completed.All specifications were met indicating the lot is performing acceptably.Labeling was reviewed which adequately addresses the current issue.Based on our investigation, no systemic issue or deficiency with the creatinine2 reagent for lot 76220ud00 was identified.
Event or Problem Description
The customer observed falsely elevated creatinine2 on the alinity c processing module for multiple patients.The following results were provided (reference range 0.50 ¿ 1.40 mg/dl): (b)(6) 2025, sid (b)(6), 66-year-old female, initial creatinine result= 2.58 mg/dl; repeat result= 0.57 mg/dl.(b)(6) 2025, sid (b)(6), 59-year-old male, initial creatinine result= 3.47 mg/dl; repeat result= 0.83 mg/dl.(b)(6) 2025, sid (b)(6), 41-year-old female, initial creatinine result= 5.39 mg/dl; repeat result= 1.35 mg/dl.Update, additional patient results were provided on 07jan2026.Sid (b)(6), 55-year-old male, initial creatine result= 2.0 mg/dl; repeat result= 0.46 mg/dl.Sid (b)(6), 79-year-old female, initial creatine result= 3.73 mg/dl; repeat result= 0.82 mg/dl.Sid (b)(6), 64-year-old female, initial creatine result= 2.17 mg/dl; repeat result= 0.50 mg/dl.Sid (b)(6), 47-year-old female, initial creatine result= 2.62 mg/dl; repeat result= 0.55 mg/dl.Sid (b)(6), 73-year-old female, initial creatine result= 2.99 mg/dl; repeat result= 0.69 mg/dl.Sid (b)(6), 81-year-old male, initial creatine result= 4.21 mg/dl; repeat result= 1.03 mg/dl.Sid (b)(6), 66-year-old female, initial creatine result= 2.73 mg/dl; repeat result= 0.61 mg/dl.Sid (b)(6), 33-year-old male, initial creatine result= 3.82 mg/dl; repeat result= 0.87 mg/dl.Sid (b)(6), 71-year-old female, initial creatine result= 4.97 mg/dl; repeat result= 1.19 mg/dl.Sid (b)(6), 71-year-old female, initial creatine result= 2.02 mg/dl; repeat result= 0.47 mg/dl.Sid (b)(6), 74-year-old male, initial creatine result= 3.06 mg/dl; repeat result= 0.70 mg/dl.Sid (b)(6), 34-year-old male, initial creatine result= 4.60 mg/dl; repeat result= 1.12 mg/dl.Sid (b)(6), 76-year-old male, initial creatine result= 3.28 mg/dl; repeat result= 0.73 mg/dl.Sid (b)(6), 82-year-old female, initial creatine result= 2.78 mg/dl; repeat result= 0.62 mg/dl.Sid (b)(6), 75-year-old male, initial creatine result= 3.63 mg/dl; repeat result= 0.84 mg/dl.There was no impact to patient management reported.

• 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 ; 6122582960
• MDR Report Key: 23906618
• Report Number: 3005094123-2025-00666
• Device Sequence Number: 21323146
• Product Code: CGX
• UDI-Device Identifier: 00380740159528
• UDI-Public: (01)00380740159528(17)260812(10)76220UD00
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K210452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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: 08/12/2026
• Device Catalogue Number: 04T91-20
• Device Lot Number: 76220UD00
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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: 66 YR
• Patient Sex: Female