BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT KAOLIN CARTRIDGE

    MDR report key: 19811415 · Received July 23, 2024

    Report

    Report Number
    2245578-2024-00146
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    July 11, 2024
    Report Date
    August 16, 2024
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JBP
    PMA / PMN Number
    K023582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 15-AUG-2024. RETAINED AND RETURNED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA IN APPENDIX 1 OF Q04.01.003 REV. AN (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). ALTHOUGH RETAINED AND RETURNED CARTRIDGE TESTING DOES NOT FAIL FOR POINTS OUTSIDE ALLOWABLE ERROR (EA), THE OUTCOME OF THIS INVESTIGATION IS THAT THERE IS EVIDENCE THAT THERE ARE COVERS MANUFACTURED IN ACT KAOLIN CARTRIDGE LOT R24125 THAT DO NOT HAVE PRINT ON THE COVER. THESE MISSING PRINT COVERS WILL GENERATE RESULTS >1000 SECONDS WHICH WERE SEEN IN BOTH FINISHED GOODS AND RETURNED CARTRIDGE TEST EVENTS. A DEFICIENCY HAS BEEN IDENTIFIED FOR ACT KAOLIN CARTRIDGE LOT R24125 FOR MISSING COVER PRINT. QUALITY RECORD (QR) 993691 HAS BEEN INITIATED TO ADDRESS ROOT CAUSE.

    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

    NA.

    Description of Event or Problem · 0

    ON 12-JUL-2024, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT ACT KAOLIN CARTRIDGES THAT YIELDED A DISCREPANT RESULTS ON A 6 MONTH OLD FEMALE IN FOR CARDIAC BYPASS. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULTS HEP/TIME DOSE COMMENT: I-STAT (B)(6) 2024 NI 09:19 134 NA N/A BASELINE TEST; NA (B)(6) 2024 NA 10:01 3050 U; I-STAT (B)(6) 2024 09:32 09:32 >1000 SEC; I-STAT (B)(6) 2024 10:06 10:06 598 SEC. CUSTOMER STATES THAT PROTAMINE WAS ONLY USED AFTER TESTING WAS COMPLETE AND COMING OFF BYPASS. 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. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2467138 I-STAT ACT KAOLIN CARTRIDGE ACT KAOLIN CARTRIDGE JBP ABBOTT POINT OF CARE INC. NA R24125

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Female