BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX POCH-100I ANALYZER

    MDR report key: 3040272 · Received April 3, 2013

    Report

    Report Number
    1422681-2013-00006
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    SYSMEX CORP
    Product Code
    GKL
    PMA / PMN Number
    K032677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SC(B)(4) INFORMED SYSMEX AMERICA, INC ON 03/04/2013, THAT THE INVESTIGATION CONFIRMED THERE WAS POTENTIAL TO OMIT A CHARACTER, WHICH COULD BE A DECIMAL, A NUMBER, OR PART OF THE GRAPHICS FROM THE PRINTOUT DUE TO A DEFECT IN THE PRINTED CIRCUIT BOARD (PCB) OF THE INTERNAL PRINTER. THIS OMISSION OF A CHARACTER IS LIMITED TO THE THERMAL PRINTOUT AND DOES NOT AFFECT THE LCD DISPLAY OR DATA OUTPUT OF RESULTS. THE PROBABILITY OF OCCURRENCE WAS ESTIMATED AS ONE TIME OUT OF 2000 MEASUREMENTS. THE PRODUCT PROBLEM WAS IDENTIFIED AS A DEFECT OF THE PRINTED CIRCUIT BOARD (PCB) OF THE INTERNAL PRINTER. A CORRECTION OF THE AFFECTED POCH-100I ANALYZERS WILL BE PERFORMED BY REPLACING THE PRINTER PCB. OPERATORS OF THE 121 AFFECTED DEVICES WILL BE INFORMED OF A TEMPORARY COUNTERMEASURE; TO VERIFY THE PRINTOUT AGAINST THE LCD DISPLAY, OR AGAINST THE DATA TRANSMITTED TO THE LAB INFO SYSTEM UNTIL THE PCB CAN BE REPLACED. THE CORRECTION BY PCB REPLACEMENT IS TARGETED TO BE COMPLETED IN THE NEXT 90 DAYS.

    Description of Event or Problem · 1

    THE OPERATOR REPORTED THAT THE THERMAL PRINTOUT ON THEIR POCH-100I AUTOMATED HEMATOLOGY ANALYZER INTERMITTENTLY DISPLAYED A NEUTROPHIL PERCENTAGE (NEUT%) FROM THE WHITE BLOOD CELL (WBC) DIFFERENTIAL WITHOUT A DECIMAL POINT. THE VALUE WAS CORRECT, BUT LACKED THE DECIMAL CAUSING THE NEUT% TO BE A NONSENSICAL VALUE. THE PRINTOUTS WERE FROM THE QC MODE, AND NO IMPACT TO PT TREATMENT AS A RESULT OF THE MISSING DECIMAL POINT WAS ALLEGED. THE COMPLAINT WAS ESCALATED TO SYSMEX CORP (B)(4) (SCJ) FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136569 SYSMEX POCH-100I ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKL SYSMEX CORP POCH-1000I F1844

    Patients

    Seq Age Sex Outcome Treatment
    1 Other