I-STAT CHEM8+ CARTRIDGE
Received Jun 17, 2026 · Event occurred May 19, 2026
Report 2245578-2026-00132 · MDR key 25531414
Device
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 22-MAY-2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED DISCREPANT POTASSIUM RESULTS ON A PATIENT THERE WAS NO PATIENT INFORMATION, NO PRODUCT LOT#, NOR DETAILS SURROUNDING THE EVENT AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: DATE: COLLECTED: TESTED: RESULT: SAMPLE: ALINITY, (B)(6) 2026, 18:14, 18:14, >9.0 MMOL/L, A; ALINITY, (B)(6) 026, 18:21, 18:21, >9.0 MMOL/L, B; LAB, (B)(6) 2026, 16:05, 18:52, 4.5 MMOL/L, C; 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.