BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT 5DIFF RINSE

    MDR report key: 3173806 · Received June 17, 2013

    Report

    Report Number
    1061932-2013-01169
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JCB
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 INSPECTED AND REPLACED APERTURE, REPLACED O-RINGS, AND WHITE BLOOD CELL (WBC) BATH. UPON FURTHER INSPECTION, THE FSE OBSERVED MUCUS LIKE SUBSTANCE ON AN OLD ELECTRODE THAT HAD JUST BEEN REMOVED. THE FSE RAN SEVERAL SAMPLES AND THE MUCUS SUBSTANCE APPEARED ON THE WBC ELECTRODE AGAIN. THE FSE DISCOVERED THE MUCUS SUBSTANCE WAS IN THE RINSE REAGENT BOTTLE. PER PHONE CONVERSATION WITH THE CUSTOMER, THE SUBJECT REAGENT HAD BEEN IN USE FOR 11 DAYS WHEN THE ISSUE WAS OBSERVED. NO RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY; SAMPLES WERE SENT OUT FOR ANALYSIS. THE FSE DECONTAMINATED THE INSTRUMENT AND REPLACED THE RINSE REAGENT WITH A NEW BOTTLE, EXPIRATION DATE 03/20/2014, AND VERIFIED THE INSTRUMENT'S OPERATION. FAILURE MODE WAS ATTRIBUTED TO THE MUCUS LIKE SUBSTANCE PRESENT IN THE RINSE REAGENT BOTTLE. IT IS UNKNOWN HOW THE REAGENT GOT CONTAMINATED. THE ANALYZER GENERATED MESSAGES FOR SOME PARAMETERS WHICH ALERTED THE CUSTOMER TO REVIEW THE RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE COULTER AC T 5DIFF CP ANALYZER WAS GIVING WHITE BLOOD COUNT (WBC) *, VOTING OUT, AND GIVING NO NUMERICAL WBC RESULTS ON MULTIPLE PATIENT SAMPLES. THE CUSTOMER INDICATED THAT PATIENT #1 ¿ PATIENT # 4 SAMPLES WERE DRAWN ON (B)(6) 2013 AND WERE ANALYZED THE SAME DAY IN THE HOSPITAL LABORATORY (REFERENCE LABORATORY). THE HOSPITAL'S RESULTS WERE CONSIDERED CORRECT. THE PATIENT SAMPLES WERE RUN FOUR DAYS LATER ((B)(6) 2013) ON THE ACT 5DIFF CP INSTRUMENT, WHICH RECOVERED LOW COMPLETE BLOOD COUNT/DIFFERENTIAL (CBC/DIFF) RESULTS WITH AND WITHOUT THE INSTRUMENT GENERATED MESSAGES ON EACH PARAMETER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO DEATH, INJURY OR EFFECT TO PATIENT TREATMENT. PATIENT # 6 RESULTS OBTAINED FROM THIS ANALYZER ON (B)(6) 2013 IS DOCUMENTED IN MDR 1061932-2013-01170. TWO (2) MDRS ARE BEING SUBMITTED FOR THE ERRONEOUS CBC/DIFF RESULTS OBTAINED AT THIS CUSTOMER SITE: 1061932-2013-01169, 1061932-2013-01170.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274129 ACT 5DIFF RINSE DETERGENT JCB BECKMAN COULTER NA 13002C00424

    Patients

    Seq Age Sex Outcome Treatment
    1