BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT KAOLIN CARTRIDGE

    MDR report key: 3003798 · Received March 14, 2013

    Report

    Report Number
    2245578-2013-00027
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JBP
    PMA / PMN Number
    K023582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON (B)(4) 2013. RETAIN AND RETURNED CARTRIDGES WERE TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    NA.

    Description of Event or Problem · 1

    ON (B)(6) 2013, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT KAOLIN CARTRIDGES THAT YIELDED UNEXPECTED RESULTS ON A 71 YEAR OLD FEMALE PRESENTED WITH ATRIAL FIBRILLATION IN THE CATH LAB. THE PATIENT HAD 5 SAMPLES RUN ON MULTIPLE ANALYZERS THAT DISPLAYED RESULTS OF >1000.THERE WAS NO OTHER PATIENT INFORMATION OR MEDICATION PROVIDED AT THE TIME OF THIS REPORT. DATE AND TIME ACT HEPARIN (B)(6) 2013 9:10 138 10,000U (B)(6) 2013 9:57 259 (B)(6) 2013 10:22 >1000 8,000 U (B)(6) 2013 10:36 >1000 (B)(6) 2013 10:47 336 (B)(6) 2013 10:53 >1000 (B)(6) 2013 11:05 287 (B)(6) 2013 11:12 NA 5,000U(B)(6) 2013 11:30 430 (B)(6) 2013 11:49 424 (B)(6) 2013 12:09 >1000 (B)(6) 2013 12:23 >1000 (B)(6) 2013 12:40 441 (B)(6) 2013 13:38 160 CUSTOMER STATES THAT NO DIFFERENT TYPE OR BRAND OF HEPARIN WAS BEING USED, NO HEPARINIZED SYRINGES COULD HAVE BEEN MIXED IN WITH THE PLAIN SYRINGES, AND NO NEW STAFF DRAWING SAMPLES OR PHYSICIANS. BASED ON THE INFORMATION AT THIS TIME THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107471 I-STAT ACT KAOLIN CARTRIDGE ACT KAOLIN CARTRIDGE JBP ABBOTT POINT OF CARE NA S12293

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR