I-STAT CHEM8+ CARTRIDGE
Received Jun 10, 2026 · Event occurred Apr 16, 2026
Report 2245578-2026-00123 · MDR key 25455809
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
64 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON (B)(6) 2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED A DISCREPANT HEMATOCRIT RESULT ON A 64-YEAR-OLD MALE PATIENT WITH A MALIGNANT TUMOR. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. PRODUCT LOT# IS UNKNOWN. METHOD / DATE / TESTED / HGB / HCT= I-STAT, (B)(6) 2026, 14:00, 11.6 G/DL, 34 %PCV / MINDRAY, (B)(6) 2026, 14:06, 6.1 G/DL, 20.7 %PCV. ALL VENOUS SAMPLES. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THE INVESTIGATION IS UNDERWAY.
Additional Manufacturer Narrative
APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.