BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT KAOLIN CARTRIDGE

    MDR report key: 2678722 · Received July 27, 2012

    Report

    Report Number
    2245578-2012-00371
    Event Type
    Malfunction
    Date Received
    July 27, 2012
    Date of Event
    June 28, 2012
    Report Date
    June 28, 2012
    Manufacturer
    ABBOTT POINT OF CARE, INC.
    Product Code
    JBP
    PMA / PMN Number
    K023582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 A HIGH RATE OF MULTIPLE QUALITY CHECK CODES (QCC) 31, 22, AND 25 DURING PATIENT TESTING. THE CUSTOMER WAS USING MULTIPLE ANALYZERS AND 3 DIFFERENT LOTS OF CARTRIDGES. LOT#: S12048B, YIELD RATE: 75% QCC. LOT#: S12122, YIELD RATE: 10% QCC. LOT#: S12105, YIELD RATE: 60% QCC. LOT#: S12122B, MANUFACTURE DATE: 05/2012, EXPIRATION DATE: 10/28/2012. LOT#: S12105, MANUFACTURE DATE: 04/2012, EXPIRATION DATE: 09/28/2012. BASED ON THE INFORMATION AVAILABLE AT THE TIME, THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT. YIELD RATES REPORTED BY THE CUSTOMER ARE UNCONFIRMED. AT THIS TIME ABBOTT POINT OF CARE HAS NO REASON TO BELIEVE THAT A MALFUNCTION EXISTS. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT ACT KAOLIN CARTRIDGE ACT KAOLIN CARTRIDGE JBP ABBOTT POINT OF CARE, INC. NA S112048B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK