BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT PAK REAGENT KIT

    MDR report key: 4796000 · Received May 26, 2015

    Report

    Report Number
    1061932-2015-00855
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    April 29, 2015
    Report Date
    April 29, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON ROOT CAUSE, THE SUSPECT PRODUCT WAS IDENTIFIED TO BE THE REAGENT(S) USED WITH THE INSTRUMENT. THE FIRST PRODUCT IS LISTED; SUBSEQUENT PRODUCTS ARE PROVIDED HERE; IT IS UNKNOWN WHICH LOTS WERE IN USE AT THE TIME OF THE EVENT. THEREFORE, EXPIRATION DATE AND DEVICE MANUFACTURING DATE ARE ALSO UNKNOWN FOR THIS EVENT. BRAND NAME: COULTER ACT PAK REAGENT KIT; CATALOG #: 8547110; LOT #: 112079K THROUGH 112094K. BRAND NAME: COULTER ACT TAINER REAGENT KIT; CATALOG #: 8547111; LOT #: 113075K THROUGH 113087K. BRAND NAME: COULTER DIFF ACT PAK, 15L; CATALOG #: 8547134; LOT #: 112077K THROUGH 112097K. BRAND NAME: COULTER DIFF ACT TAINER 4L; CATALOG #: 8547135; LOT #: 113074K THROUGH 113090K. NEW INFORMATION ABOUT THE ROOT CAUSE WAS COMPLETED ON (B)(6) 2015. ROOT CAUSE CHANGED THE 510K FROM K973634 TO EXEMPT TO CORRELATE TO THE PRODUCT. METHOD, RESULTS AND CONCLUSION CHANGED BASED ON ROOT CAUSE; PATIENT AND PRODUCT CODES ADDED, AS THE FIELDS IN THE 3500A FORM HAVE BEEN UPDATED SINCE THE INITIAL REPORT. A RECALL WAS COMPLETED AND AN IMPORTANT PRODUCT NOTICE LETTER WAS SENT TO CUSTOMERS ON 08/25/2015. THE ROOT CAUSE HAS BEEN IDENTIFIED AS LOT TO LOT VARIATION IN THE SODIUM SULFATE USED IN THE REAGENT, WHICH RESULTED IN A COMPROMISED WHITE BLOOD CELL (WBC) BATH IN THIS EVENT. IN ADDITION, THE INVESTIGATION FOUND THAT THE ROOT CAUSE IDENTIFIED WOULD NOT CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH AS THE PROBABILITY OF HARM PER THE RISK ASSESSMENT IS HIGHLY UNLIKELY AND NOT A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON 04/30/2015. THE FSE REPLACED THE WBC BATH, RESOLVING THE REPORTED ISSUE. THE REPAIR WAS VERIFIED PER ESTABLISHED SERVICE PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECOVERING LOW HEMOGLOBIN (HGB) RESULTS AND INCOMPLETE WHITE BLOOD CELL (WBC) AND DIFFERENTIAL (DIFF) RESULTS WHILE RUNNING CONTROLS ON A COULTER ACT DIFF ANALYZER. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340142 COULTER ACT PAK REAGENT KIT COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA 112079K

    Patients

    Seq Age Sex Outcome Treatment
    1