I-STAT CREATININE CARTRIDGE
Received May 13, 2026 · Event occurred Apr 29, 2026
Report 2245578-2026-00108 · MDR key 25162634
Device
Generic name
Crea Cartridge
Manufacturer
Abbott Point Of Care Inc.Model number
NACatalog number
03P84-25
Lot number
A26041
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.
Description of Event or Problem
ON 01-MAY-2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULT ON A PATIENT. THERE WAS NO PATIENT INFORMATION, NOR DETAILS SURROUNDING THE EVENT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: DATE: RESULT: I-STAT, (B)(6) 2026 6.1; LAB, (B)(6) 2026 0.2. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE INVESTIGATION IS UNDERWAY.