BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT PAK REAGENT KIT

    MDR report key: 4116332 · Received September 24, 2014

    Report

    Report Number
    1061932-2014-02455
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    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. THE MANUFACTURING SITE ADDRESS HAS BEEN UPDATED TO CORRELATE TO THE PRODUCT. NEW INFORMATION ABOUT THE ROOT CAUSE WAS COMPLETED ON 8/12/2015. ROOT CAUSE CHANGED THE 510K FROM K973634 TO EXEMPT TO CORRELATE TO THE PRODUCT. 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

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE WHITE BLOOD CELL (WBC) CHAMBER DIRTY AND UNSTABLE AND REPLACED THE WBC BATH TO RESOLVE THE REPORTED ISSUE. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO THE WHITE BLOOD CELL (WBC) BATH. A DEFINITIVE ROOT CAUSE IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED VOTE-OUTS FOR WHITE BLOOD CELL (WBC) AND HEMOGLOBIN (HGB) PARAMETERS, INVOLVING THE COULTER ACT DIFF 2 ANALYZER. THE CUSTOMER STATED NO ERRONEOUS PATIENT RESULTS WERE GENERATED AS PATIENT SAMPLES WERE NOT ANALYZED AT THE TIME OF THE EVENT. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) ASSESSED THE INSTRUMENT AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593901 COULTER ACT PAK REAGENT KIT COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA 112079K

    Patients

    Seq Age Sex Outcome Treatment
    1