I-STAT CREATININE CARTRIDGE
Received Jun 10, 2026 · Event occurred May 29, 2026
Report 2245578-2026-00125 · MDR key 25455815
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
83 YR · Male
- 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 (B)(6) 2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULT ON A 83 YEAR OLD PATIENT. THERE WAS NO PATIENT INFORMATION, NOR DETAILS SURROUNDING THE EVENT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. PRODUCT LOT# IS UNKNOWN. METHOD CREA EGFR. LAB 138 UMOL/L, 40 . I-STAT 336 UMOL/L, 14. I-STAT 342 UMOL/L, 13. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE INVESTIGATION IS UNDERWAY.