BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT KAOLIN CARTRIDGE

    MDR report key: 25301646 · Received May 27, 2026

    Report

    Report Number
    2245578-2026-00117
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    May 7, 2026
    Report Date
    May 27, 2026
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JBP
    UDI-DI
    10054749000156
    PMA / PMN Number
    K023582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT ACT KAOLIN CARTRIDGES THAT YIELDED A DISCREPANT RESULTS ON A 79-YEAR-OLD MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. DATE: TESTED RESULTS: HEPARIN. HEPARIN TIME: (B)(6) 2026 3100 (UNITS HR). 11:38 (B)(6) 2026 21,000. 11:39 (B)(6) 2026 12:30 271. (B)(6) 2026 5,000. 12:31 (B)(6) 2026 12:56 >1000. (B)(6) 2026 12:56 >1000. (B)(6) 2026 13:16 >1000. (B)(6) 2026 13:16 >1000. (B)(6) 2026 13:18 >1000. (B)(6) 2026 13:32 199. (B)(6) 2026 13:32 214. (B)(6) 2026 13:39 209. (B)(6) 2026 13:39 209. (B)(6) 2026 5,0000. 13:42 (B)(6) 2026 13:52 225. (B)(6) 2026 13:53 245. (B)(6) 2026 3,100 (UNIT/HR). 13:53 (B)(6) 2026 8,000 13:55 (B)(6) 2026 14:05 291. (B)(6) 2026 14:05 281. (B)(6) 2026 5,000. 14:07 (B)(6) 2026 14:20 368. (B)(6) 2026 14:31 >1000. (B)(6) 2026 14:51 301. (B)(6) 2026 14:53 373. (B)(6) 2026 15:23 199. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423745 I-STAT ACT KAOLIN CARTRIDGE ACT KAOLIN CARTRIDGE JBP ABBOTT POINT OF CARE INC. NA R25343 10054749000156

    Patients

    Seq Age Sex Outcome Treatment
    1