BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT KAOLIN CARTRIDGE

    MDR report key: 4491798 · Received February 6, 2015

    Report

    Report Number
    2245578-2015-00005
    Event Type
    Malfunction
    Date Received
    February 6, 2015
    Date of Event
    January 13, 2015
    Report Date
    January 14, 2015
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JBP
    PMA / PMN Number
    K023582
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON 04/14/2015. RETAIN AND RETURNED PRODUCT WAS TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    NA

    Description of Event or Problem · 1

    ON (B)(6) 2015, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT KAOLIN CARTRIDGE THAT YIELDED UNEXPECTED RESULTS ON A PATIENT UNDERGOING A PROCEDURE IN THE CATH LAB. CUSTOMER IS RETURNING PRODUCT FOR INVESTIGATION. TIME I-STAT I-STAT HEPARIN HEPARIN TIME0754 132 10,000 PRIME UNK0836 337 25,000 08330849 299 10,000 08450916 420 376 10,000 09100927 321 - - -0938 426 5,000 09351000 243 243 - -1015 >1000 10,000 10071045 376 >1000 - -1110 359 315 - -1125 - - 5,000 11201127 382 276 - -1145 277 282 5,000 11401200 >1000 243 - -1225 293 >1000 7,000 12081250 265 288 - -1315 193 - - -THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87889 I-STAT ACT KAOLIN CARTRIDGE ACT KAOLIN CARTRIDGE JBP ABBOTT POINT OF CARE NA T14259A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR