BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I STAT ACT KAOLIN CARTRIDGE

    MDR report key: 2615598 · Received June 8, 2012

    Report

    Report Number
    2245578-2012-00357
    Event Type
    Malfunction
    Date Received
    June 8, 2012
    Date of Event
    May 10, 2012
    Report Date
    May 10, 2012
    Manufacturer
    ABBOTT POINT OF CARE INC.
    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).

    Description of Event or Problem · 1

    ON (B)(6) 2012, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT KAOLIN CARTRIDGES THAT YIELDED MULTIPLE QUALITY CHECK CODES (QCC) 22, 31, 39 & 44 DURING PT TESTING USING MULTIPLE ANALYZERS. TIME 10:21, SAMPLE TYPE: QCC, DEVICE 313746. TIME: 10:23, PT, 313746. TIME: 10:37, QCC, 313746. TIME: 10:38, PT, 300151. TIME: 10:40, QCC, 313746. TIME: 10:43, QCC, 313746. TIME: 10:44, EQC, 300151. 10:46, QCC, 300151. TIME: 11:05, QCC, 313746. TIME: 11:05, PT, 300151. TIME: 11:07, QCC, 313746. TIME: 11:09, PT, 300151. BASED ON THE INFO AVAILABLE AT THE TIME, THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I STAT ACT KAOLIN CARTRIDGE ACT KAOLIN KARTRIDGE JBP ABBOTT POINT OF CARE INC. BA S12106

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR