MAUDE Adverse Event Report: Abbott Laboratories ARCHITECT c4000 Processing Module; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	02P24-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete entry for section a1 - patient identifier: (b)(6).Section a patient information: refer to section b5 for complete patient information.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated creatinine results generated on the architect c4000 instrument for a.The following data was provided: (patient normal ranges: adult male 0.73-1.18 mg/dl, adult female 0.55-1.02 mg/dl) patient 1 (b)(6) 2026, 22-year-old female sid (b)(6) initial result 5.87 mg/dl (on (b)(6) repeated 0.73 and 0.69 mg/dl (the patient sample was sent to a sister hospital and repeated on two separate alinity c analyzers).The patient was sent to emergency room at sister hospital, and a sample was drawn that yielded normal results.The patient did not receive any treatment.Patient 2 (b)(6) 2026, 29-year-old female sid (b)(6) initial result 2.02 mg/dl (on (b)(6), repeated 0.61 and 0.57 mg/dl (patient sample was sent to a sister hospital and repeated on two separate alinity c analyzers) no impact to patient management was reported.

• Brand Name: ARCHITECT c4000 Processing Module
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): Abbott Laboratories; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): Abbott Laboratories; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; +49()6122582960
• MDR Report Key: 50944582
• Report Number: 3016438761-2026-00542
• Device Sequence Number: 9534597
• Product Code: JJE
• UDI-Device Identifier: 00380740003746
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 02P24-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: MLTGNT ENZY CREAT 750T, 08L24-31, 51330Y600
• Patient Sex: Female