inforMED
MalfunctionJBP

I-STAT ACT KAOLIN CARTRIDGE

Received Jun 23, 2026 · Event occurred Jun 8, 2026

Report 2245578-2026-00137 · MDR key 25597712

Device

Generic name

Act Kaolin Cartridge

Model number

NA

Catalog number

03P87-25

Lot number

R26031

Product problems

  • Incorrect, Inadequate or Imprecise Result or Readings

Patient

Not reported

  • 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 08-JUN-2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT ACT KAOLIN CARTRIDGES THAT YIELDED A DISCREPANT RESULT ON A PATIENT. THERE WAS PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. TESTED: RESULT: 11:36, 798 SEC; 11:45, 291 SEC. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. AN INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL (ART: 714185-00Q), THE I-STAT KAOLIN ACTIVATED CLOTTING TIME (KAOLIN ACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD. AND IS USED TO MONITOR HIGH-DOSE HEPARIN ANTICOAGULATION FREQUENTLY ASSOCIATED WITH CARDIOVASCULAR SURGERY.