BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3132612 · Received May 29, 2013

    Report

    Report Number
    1061932-2013-00965
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 5, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE WAS COLLECTED IN A 4 ML EDTA VACUTAINER TUBE AND IT WAS LESS THAN 24 HOURS OLD AND STORED REFRIGERATED POST ANALYSIS. CONTROLS WERE RUN BEFORE AND AFTER THIS EVENT AND ALL RECOVERED WITHIN SPECIFICATION. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN SPECIFICATION. PER CUSTOMER, VARIANT LYMPH AND LEFT SHIFT SENSITIVITIES WERE SET TO HIGH SENSITIVITY AND IMM GRANULOCYTES WAS SET TO MEDIUM SENSITIVITY. THE CUSTOMER HAVE SINCE CHANGED THE FLAGGING LEVEL FOR IMM GRANULOCYTES TO HIGH SENSITIVITY. THERE WAS NO SERVICE DISPATCHED FOR THIS EVENT. RAW DATA HAS BEEN RECEIVED AND PENDING ANALYSIS. THE ROOT CAUSE FOR THE MISSING BLAST FLAGGING IS UNKNOWN. PER LABELING, BECKMAN COULTER DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN SAMPLES AND SUGGESTS USING ALL AVAILABLE FLAGGING OPTIONS TO OPTIMIZE THE SENSITIVITY OF THE INSTRUMENT RESULTS. ALL FLAGGING OPTIONS INCLUDE REFERENCE RANGES (H/L), CODES, AND FLAGS. BECKMAN COULTER RECOMMENDS AVOIDING THE USE OF SINGLE MESSAGES OR OUTPUTS TO SUMMARIZE SPECIMEN RESULTS OR PATIENT CONDITIONS. THE FOLLOWING MDRS ARE BEING SUBMITTED FOR THIS ISSUE FROM THIS ACCOUNT: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEMS (SN (B)(4)) 1061932-2013-00963, 1061932-2013-00965. UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEMS (SN (B)(4)) 1061932-2013-00964.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM (SN (B)(4)) DID NOT PROVIDE BLAST SUSPECT MESSAGES FOR A SINGLE PATIENT DIAGNOSED WITH AN ACUTE LEUKEMIA WHEN 25% BLASTS WERE SEEN ON THE MANUAL FILM. THIS REPORT IS FOR THE SAMPLE TESTED ON (B)(6) 2013. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO DEATH OR INJURY ASSOCIATED WITH THIS COMPLAINT. CLARIFICATION OF PATIENT TREATMENT ATTRIBUTED TO THIS ISSUE (IF ANY) HAS BEEN REQUESTED AND PENDING RESPONSE FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234978 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER DXH 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR