BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COULTER® ACT DIFF 2? ANALYZER

    MDR report key: 3490569 · Received November 26, 2013

    Report

    Report Number
    1061932-2013-02671
    Event Type
    Injury
    Date Received
    November 26, 2013
    Date of Event
    October 31, 2013
    Report Date
    November 1, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PROVIDED PATIENT DATA DEMONSTRATED THAT ON THE FINGER STICK SAMPLE OBTAINED LOWER WBC, RBC, HGB, HCT, MCHC AND PLTS AND HIGHER MCV, RDW AND MPV RESULTS WITH INSTRUMENT SPECIFIC FLAGGING WERE OBTAINED WHEN COMPARED TO THE VENOUS SAMPLE THAT WAS DRAWN AT THE HOSPITAL ON THE SAME DAY AND RE-DRAW RESULTS FROM THE FOLLOWING DAY. DIFFERENTIAL RESULTS RECOVERED WITH REGION 1 FLAGS; THE RE-RUN SAMPLES WERE CONSIDERED CORRECT. THE INSTRUMENT PROVIDED SYSTEM SPECIFIC FLAGGING FOR WBC, PLT AND DIFFS ALERTING THE OPERATOR TO REVIEW THE SAMPLE. HOWEVER NO MANUAL SLIDE REVIEW WAS PERFORMED TO CONFIRM THE PATIENT'S PLT RESULTS AND IT IS NOT KNOWN IF THE LAB CHECKED FOR SAMPLE INTEGRITY. A FIELD SERVICE ENGINEER WAS DISPATCHED. THE FSE COULD NOT REPRODUCE THE ISSUE. THE INSTRUMENT WAS VERIFIED AND MET ALL SPECIFICATIONS. THE FAILURE MODE CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED. RESULTS SEEM TO POINT TO A PRE-ANALYTICAL CONDITION FOR THE FINGER STICK SAMPLE. HOWEVER, THE INSTRUMENT PROVIDED SYSTEM SPECIFIC FLAGGING FOR WBC, PLT AND DIFFS ALERTING THE OPERATOR TO REVIEW THE SAMPLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING LOW HGB AND PLT RESULTS WITH REGION 1 FLAGS ON A FINGER STICK SAMPLE FOR A SINGLE PATIENT RUN ON THE ACT DIFF 2. ERRONEOUS PATIENT RESULTS WERE REPORTED OUTSIDE THE LABORATORY, HOWEVER THERE WAS NO DEATH OR INJURY ASSOCIATED WITH THIS EVENT. THE CUSTOMER STATED THAT THE PATIENT WAS RUNNING A VERY HIGH FEVER. DUE TO THE FEVER AND THE LOW RESULTS OBTAINED FROM THE ACT DIFF 2, THE PATIENT WAS SENT TO THE HOSPITAL TO BE REDRAWN. THE CUSTOMER STATED RESULTS FROM THE HOSPITAL YIELDED HIGHER HGB AND PLT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614860 COULTER® ACT DIFF 2? ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER AC*T DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization