BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT 5DIFF CP

    MDR report key: 2103128 · Received May 25, 2011

    Report

    Report Number
    1061932-2011-00487
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 23, 2011
    Report Date
    April 25, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION INFORMATION WAS NOT PROVIDED FOR THIS EVENT. INSTRUMENT WAS PERFORMING WITHIN QC SPECIFICATIONS. BCI FIELD SERVICE ENGINEER (FSE) CLEANED AND LUBRICATED THE TRANSVERSE GUIDERAILS AND SAMPLE SYRINGE; REPLACED THE RINSE BLOCK ASSEMBLY, PIERCING NEEDLE AND SAMPLE PROBE. ROOT CAUSE CAN BE ATTRIBUTED TO THE HARDWARE REPLACED BY THE FSE DURING SUBSEQUENT INSTRUMENT SERVICING FOR THIS EVENT. PER LABELING, BECKMAN COULTER INC. DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN ALL SAMPLES. BECKMAN COULTER SUGGESTS USING ALL AVAILABLE FLAGGING OPTIONS TO OPTIMIZE THE SENSITIVITY OF INSTRUMENT RESULTS. ALL FLAGGING OPTIONS INCLUDE PATIENT LIMITS (H/L), ACTION LIMITS (HH/LL), PARAMETER FLAGS, INTERPRETIVE MESSAGES AND ANALYTICAL ALARMS. BECKMAN COULTER RECOMMENDS AVOIDING THE USE OF SINGE MESSAGES OR OUTPUTS TO SUMMARIZE SPECIMEN RESULTS OR PATIENT CONDITIONS. ADDITIONALLY, IT IS RECOMMENDED THAT PLATELET COUNTS LESS THAN 20 X 103/UL BE REVIEWED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) TO REPORT THAT THE COULTER ACT 5DIFF CAP PIERCE INSTRUMENT GENERATED LOW RBC AND HGB RESULTS ON TWO (2) PATIENT SAMPLES WITH NO FLAGS. ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. REPEAT TESTING ON THE SAME DAY FOR ONE (1) PATIENT AND TWO (2) DAYS LATER FOR THE SECOND PATIENT GENERATED RESULTS THAT WERE CONSIDERED CORRECT. PATIENT TREATMENT WAS NOT AFFECTED AND THERE HAS BEEN NO DEATH OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACT 5DIFF CP AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. ACT 5DIFF CP NA

    Patients

    Seq Age Sex Outcome Treatment
    1