I-STAT CHEM8+ CARTRIDGE
Received Jun 17, 2026 · Event occurred May 10, 2026
Report 2245578-2026-00136 · MDR key 25531415
Device
Generic name
Chem8+ Cartridge
Manufacturer
Abbott Point Of CareModel number
NACatalog number
09P31-25
Lot number
H25355
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 (B)(6) 2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED DISCREPANT POTASSIUM RESULTS ON A PATIENT. THERE WERE NO RESULTS, NO PATIENT INFORMATION, NOR DETAILS SURROUNDING THE EVENT AVAILABLE AT THE TIME OF THE INITIAL REPORT. ON (B)(6) 2026 RESULTS WERE PROVIDED. HOWEVER, NO PATIENT INFORMATION NOR DATAILS SURROUNDING THE REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD. DATE .TESTED. RESULT. I-STAT. (B)(6) 2026. 09:53. 2.4 MMOL/L. LAB. NI. NI. 4.12. 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.