I-STAT CREATININE CARTRIDGE
Received Jan 13, 2026 · Event occurred Jan 5, 2026
Report 2245578-2026-00012 · MDR key 24059280
Device
Generic name
Crea Cartridge
Manufacturer
Abbott Point Of Care Inc.Model number
NACatalog number
03P84-25
Lot number
A25306A
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 05-JAN-2025, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULT ON A PATIENT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD RESULTS. I-STAT1 2.2 MG/DL. BECKMAN AU480 3.9 MG/DL. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE INVESTIGATION IS UNDERWAY.
Additional Manufacturer Narrative
APOC INCIDENT: (B)(4). THE INVESTIGATION WAS COMPLETED ON 27-JAN-2026. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AO, PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN IDENTIFIED FOR CREA CARTRIDGE LOT A25306A.
Description of Event or Problem
NA.