I-STAT CHEM8+ CARTRIDGE
Received Apr 1, 2026 · Event occurred Feb 22, 2026
Report 2245578-2026-00080 · MDR key 24752773
Device
Generic name
Chem8+ Cartridge
Manufacturer
Abbott Point Of CareModel number
NACatalog number
09P31-26
Lot number
H25310
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Female
- 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 CHEM8+ CARTRIDGE THAT YIELDED A DISCREPANT POTASSIUM RESULT ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD, DATE, RESULT, I-STAT, (B)(6) 2026, >9, I-STAT, (B)(6) 2026, >9, LAB, (B)(6) 2026, 3.4. 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.