I-STAT CHEM8+ CARTRIDGE
Received May 13, 2026 · Event occurred May 8, 2026
Report 2245578-2026-00110 · MDR key 25162641
Device
Generic name
Chem8+ Cartridge
Manufacturer
Abbott Point Of CareModel number
NACatalog number
09P31-25
Lot number
H26013
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
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 A DISCREPANT HEMATOCRIT RESULT ON A PATIENT. THERE WAS NO PATIENT INFORMATION, NOR DETAILS SURROUNDING THE EVENT AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE: TESTED : NA: K : CL : ICA TCO2: GLU UREA: CREA : HCT : HB: ANGAP: SAMPLE I-STAT, (B)(6) 2026 , 22:22 , 141 ,3.3, 107 ,1.25 , 22 , 5.2 , 7 , 39 , 20, 68 , 16 , ART, I-STAT, (B)(6) 2026 , 06:05 , 142, 3.1 , 106, 1.22 , 21 , 4.4 , 5.5 , 33, 21, 71, 19 , ART, I-STAT , (B)(6) 2026, 05:28 , 150, 2.9, 109, 1.33 , 19, 2.8 , <18 46, 156, 26, VEN, I-STAT , (B)(6) 2026, 13:20 , 137, 3.2, 117 ,0.91, 21, 4.6 , 3.3 , 25 , 21, 71 , 3 , ART. MMOL/L-UMOL/L / %PCV /- G/L / MMOL/L/. 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.