ALINITY C CREATININE2
Received Jun 1, 2026 · Event occurred May 12, 2026
Report 3005094123-2026-00259 · MDR key 25354424
Device
Generic name
Alkaline Picrate, Colorimetry, Creatinine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
04T91-20
Lot number
80008UD00
Product problems
- Imprecise or Erratic Results
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED IMPRECISE CREATININE 2 RESULTS GENERATED BY THE ALINITY C PROCESSING MODULE FOR A 76-YEAR-OLD MALE PATIENT. THE FOLLOWING DATA WERE PROVIDED: REFERENCE RANGE: 0.6 TO 1.2 MG/DL SID (B)(6): (B)(6) 2026 CREATININE 2 RESULTS = 0.4 MG/DL, 1.2 MG/DL. SID (B)(6): (B)(6) 2026 CREATININE 2 INITIAL RESULT = 4.7 MG/DL, REPEAT RESULT = 5.8 MG/DL. SID (B)(6): (B)(6) 2026 CREATININE 2 RESULT = 0.1 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS 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. E1 - POSTAL CODE: A LEADING ZERO WAS ADDED TO THE FIELD BECAUSE THE SYSTEM REQUIRES A MINIMUM OF 5 DIGITS IN THE POSTAL CODE FIELD.