BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 3700 SL ANALYZER

    MDR report key: 6945258 · Received October 12, 2017

    Report

    Report Number
    2919069-2017-00140
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    August 24, 2017
    Report Date
    December 19, 2017
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    UDI-DI
    00380740002725
    PMA / PMN Number
    K980614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED SAMPLE IDENTIFICATION MISMATCH ON THE CELL-DYN 3700. SID (B)(6) WAS READ AS SID(B)(6) (SEQ. 5967) BY THE ANALYZER. PER THE LOG, IT APPEARS THAT SID (B)(6) WAS RUN A SECOND TIME (SEQ. 5968), BUT THE SECOND RUN WAS MORE IN LINE WITH THE SECOND PATIENT'S HISTORICAL RESULTS. THE INITIAL RUN, SEQ. 5967, GENERATED RESULTS WHICH MATCH WITH THE REPEAT RUN OF SID(B)(6) ON SEQ. 5972. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF PRODUCT HISTORICAL DATA DID NOT IDENTIFY ANY TRENDS OR CUSTOMER COMPLAINTS FOR THIS ISSUE. A REVIEW OF THE CELL DYN 3700 LABELING ADEQUATELY ADDRESSES MESSAGES AND FLAGS THAT ARE USED TO ALERT THE OPERATOR. INSTRUCTIONS FOR INTERPRETING ALL FLAGS AND NUMERIC, SCATTER, AND HISTOGRAM DATA SHOULD BE INCORPORATED INTO THE LABORATORY'S PROCEDURE AND USED TO DETERMINE THE NEED FOR FURTHER ACTION AND/OR REVIEW OF RESULTS. BASED ON THIS INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE CELL DYN 3700 SL, LIST NUMBER 02H31-01, SERIAL NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ADDITIONAL INFORMATION (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SAMPLE IDENTIFICATION MISMATCH ON THE CELL DYN 3700. (B)(6) WAS READ AS (B)(6) BY THE ANALYZER. PER THE LOG, IT APPEARS THAT (B)(6) WAS RUN TWO TIMES. THE INITIAL (B)(6) RUN GENERATED RESULTS WHICH MATCH WITH THE REPEAT RUN OF (B)(6). THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN BUT NO TREATMENT WAS GIVEN BASED ON THOSE RESULTS. THE SECOND RUN OF (B)(6) WAS MORE IN LINE WITH THAT PATIENT'S HISTORICAL RESULTS. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726063 CELL-DYN 3700 SL ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION 00380740002725

    Patients

    Seq Age Sex Outcome Treatment
    1