BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT 5DIFF RINSE

    MDR report key: 3191488 · Received June 26, 2013

    Report

    Report Number
    1061932-2013-01172
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 1, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JCB
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE CONFIRMED THE TRANSFER SENSOR TIME OUT ERROR ALONG WITH NO WHITE BLOOD COUNT (WBC) RESULTS. THE FSE FOUND THAT A CONTAMINATED BOTTLE OF ACT 5 DIFF RINSE REAGENT HAD BEEN ON THE INSTRUMENT. THE FSE STATED THAT THE REAGENT BOTTLE APPEARED TO HAVE A "WHITE SLIME" INSIDE THE REAGENT. THE FSE THOROUGHLY DECONTAMINATED THE RINSE PICKUP TUBE AND REAGENT LINES WITH A BLEACH SOLUTION, AND PLACED A FRESH BOTTLE OF RINSE REAGENT (LOT NUMBER 13302C0327) ON THE INSTRUMENT. THE FSE ALSO BLEACHED THE DIFFERENTIAL SAMPLE PATHWAY THROUGH VALVES (VL'S 4 AND 5). AFTER MULTIPLE PRIMES, THE FSE PERFORMED A STARTUP PROCEDURE AND CYCLED CONTROLS WITH NO FURTHER ISSUES; RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. PER PHONE CONVERSATION WITH THE CUSTOMER ON (B)(6) 2013, THERE HAVE BEEN NO FURTHER PROBLEMS. THE REPLACEMENT OF THE CONTAMINATED REAGENT RESOLVED THE TRANSFER SENSOR ERROR AND THE WBC VOTE OUTS ISSUE. REAGENT LOG INFORMATION WAS REQUESTED AND HAS NOT YET BEEN RECEIVED. FAILURE MODE WAS RELATED TO A CONTAMINATED ACT5 RINSE REAGENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) A TRANSFER SENSOR TIME OUT ERROR MESSAGE ON THE COULTER ACT 5DIFF CP ANALYZER. THE CUSTOMER INDICATED THAT THE ISSUE WAS NOT RESOLVED BY ROUTINE CLEANING AND TROUBLESHOOTING PROCEDURES. THE CUSTOMER WAS ALSO EXPERIENCING NO WHITE BLOOD COUNT (WBC) RESULTS. REVIEW OF THE INSTRUMENT¿S REAGENT LOG INDICATES THAT THE ACT 5 RINSE REAGENT LOT NUMBER 12802C00022 WAS LOADED IN THE INSTRUMENT ON (B)(4) 2013 AND WAS REPLACED BY A DIFFERENT LOT, 12902C01655, ON THE SAME DAY AS THE CUSTOMER WAS TROUBLESHOOTING THE WBC RESULTS OF 0.0. PER CONVERSATION WITH THE CUSTOMER, WBC SAMPLE RESULTS WERE AT 0.0 SHORTLY AFTER THE ACT 5 RINSE REAGENT REPLACEMENT. CUSTOMER SENT ALL AFFECTED SAMPLES TO A REFERENCE LABORATORY FOR CONFIRMATION AND RESULTS FROM THE REFERENCE LABORATORY WERE REPORTED OUT AS CORRECT. PRINT OUTS WERE REQUESTED FOR REVIEW BUT WERE NOT PROVIDED. THE OPERATOR WAS WEARING A LABORATORY COAT AND GLOVES AND EYE GLASSES AT THE TIME OF THE INCIDENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND THERE WAS NO EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291311 ACT 5DIFF RINSE DETERGENT JCB BECKMAN COULTER NA 12802C00022

    Patients

    Seq Age Sex Outcome Treatment
    1