I-STAT CREATININE CARTRIDGE
Received Oct 21, 2025 · Event occurred Oct 12, 2025
Report 2245578-2025-00127 · MDR key 23349936
Device
Generic name
Crea Cartridge
Manufacturer
Abbott Point Of Care Inc.Model number
NACatalog number
03P84-25
Lot number
A25203
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
45 YR · Male
- High Blood Pressure/ Hypertension
- High Blood Pressure/ Hypertension
Narrative
Additional Manufacturer Narrative
APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 10-NOV-2025. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS (FG) 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 A25203.
Description of Event or Problem
NA.
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 (B)(6) 2025, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULT ON A 45-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY OF HYPERTENSION. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED CREA SAMPLE I-STAT. (B)(6) 2025. 11:06. 11:15. 2.1 MG/DL. A. LAB. (B)(6) 2025. 11:06. 11:29. 1.19 MG/DL. A. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE INVESTIGATION IS UNDERWAY.