BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD 22 SYSTEM

    MDR report key: 14648824 · Received June 9, 2022

    Report

    Report Number
    2919069-2022-00012
    Event Type
    Malfunction
    Date Received
    June 9, 2022
    Date of Event
    May 18, 2022
    Report Date
    August 2, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740020286
    PMA / PMN Number
    K110381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    UPDATED ADDITIONAL MFG NARRATIVE H10: A REVIEW OF PRODUCT HISTORICAL DATA FOR ANY TRENDS AND ALL CUSTOMER COMPLAINTS RECEIVED FOR THIS ISSUE DID NOT IDENTIFY ANY TRENDS OR INCREASE IN COMPLAINT ACTIVITY. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DETERMINED NO ADVERSE TREND FOR THE ISSUE FOR THE PRODUCT. THE LABORATORY NORMAL PLT RANGE IS SET AS 160-370 (X 10^9/L) ON THE ALINITY AND 140-440 (X 10^9/L) ON CD EMERALD 22. THE ALINITY RESULT FOR PATIENT B WAS 1232 G PT/L. THIS PLT RESULTS WERE FLAGGED WITH AN EXCLAMATION POINT (!) ON THE CUSTOMER REPORT INDICATING THAT THE RESULT WAS EXCEEDING THE NORMAL RANGE. TICKET NOTES INDICATED THAT THE PLT RESULTS GENERATED BY CD EMERALD 22 FOR PATIENT B WAS 830. THIS RESULT ALSO EXCEEDED THE NORMAL RANGE. A RESULT THAT FALLS OUTSIDE OF A LABORATORY ACTION LIMIT INDICATED THE NEED FOR THE OPERATOR TO FOLLOW A LABORATORY PROTOCOL, SUCH AS REPEATING THE SAMPLE, PERFORMING A SMEAR REVIEW, OR NOTIFYING THE PHYSICIAN. THE RESULTS GENERATED ON CD EMERALD 22 WERE NOT REPORTED. THERE IS FUNDAMENTAL TECHNOLOGY DIFFERENCES BETWEEN THE CD EMERALD 22 AND THE ALINITY HQ TO MEASURE PLT - THE CD EMERALD 22 USES IMPEDANCE TECHNOLOGIES AND ALINITY HQ USES OPTICAL. THE DIFFERENCES IN PLT VALUES ARE NOTICEABLE WHEN THE PLT VALUES ARE ABNORMALLY LOW OR HIGH. IN SUCH CONDITIONS, THE INSTRUMENT USUALLY WOULD FLAG THE SAMPLES AND ALERT CUSTOMERS TO PERFORM A VERIFICATION OF THE RESULTS. BASED ON THE INFORMATION PROVIDED, THE INSTRUMENT PRECISION AND CALIBRATION COULD NOT BE RULED OUT AS THE POTENTIAL CONTRIBUTING FACTORS. ADDITIONALLY, THE DIFFERENCES IN PLT RESULTS BETWEEN THE CD EMERALD 22 AND THE ALINITY HQ, ESPECIALLY WHEN THE PLT VALUES ARE ABNORMALLY HIGH OR LOW, WERE DUE TO THE TECHNOLOGY DIFFERENCES. THE CD EMERALD 22 GENERATED FLAGS INDICATING THAT THE VERIFICATION OF THE RESULTS WAS REQUIRED. PER THE CD EMERALD 22 OPERATOR¿S MANUAL (9141000F¿APRIL 2020), THE CELL-DYN EMERALD 22 HAS BEEN VALIDATED FOR ITS INTENDED USE. HOWEVER, ERROR CAN OCCUR DUE TO POTENTIAL OPERATOR ERRORS AND SYSTEM TECHNOLOGY LIMITATIONS. RESULTS OBTAINED FROM THE SYSTEM SHOULD BE USED WITH OTHER CLINICAL DATA, FOR EXAMPLE, PATIENT SYMPTOMS, OTHER TEST RESULTS, PATIENT HISTORY, CLINICAL IMPRESSIONS, INFORMATION AVAILABLE FROM CLINICAL EVALUATION, AND OTHER DIAGNOSTIC PROCEDURES. LABELING WAS FOUND TO BE ADEQUATE FOR THE COMPLAINT INCIDENT. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE CELL-DYN (CD) EMERALD 22 ANALYZER SERIAL NUMBER (B)(6).

    Additional Manufacturer Narrative · 0

    A REVIEW OF PRODUCT HISTORICAL DATA FOR ANY TRENDS AND ALL CUSTOMER COMPLAINTS RECEIVED FOR THIS ISSUE DID NOT IDENTIFY ANY TRENDS OR INCREASE IN COMPLAINT ACTIVITY. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DETERMINED NO ADVERSE TREND FOR THE ISSUE FOR THE PRODUCT. THE LABORATORY NORMAL PLT RANGE IS SET AS 160-370 (X 10^9/L) ON THE ALINITY AND 140-440 (X 10^9/L) ON CD EMERALD 22. THE ALINITY RESULT FOR PATIENT A WAS 515 G PT/L AND FOR PATIENT B WAS 1232 G PT/L. BOTH OF THE PLT RESULTS WERE FLAGGED WITH AN EXCLAMATION POINT (!) ON THE CUSTOMER REPORT INDICATING THAT THE RESULT WAS EXCEEDING THE NORMAL RANGE. TICKET NOTES INDICATED THAT THE PLT RESULTS GENERATED BY CD EMERALD 22 FOR PATIENT B WAS 830. THIS RESULT ALSO EXCEEDED THE NORMAL RANGE. A RESULT THAT FALLS OUTSIDE OF A LABORATORY ACTION LIMIT INDICATED THE NEED FOR THE OPERATOR TO FOLLOW A LABORATORY PROTOCOL, SUCH AS REPEATING THE SAMPLE, PERFORMING A SMEAR REVIEW, OR NOTIFYING THE PHYSICIAN. THE PLT RESULTS GENERATED BY THE CD EMERALD 22 FOR SPECIMEN ID (SID) 541913, 541914, 541915, AND 541932 WERE ALL FLAGGED AS BELOW THE LOWER PATIENT LIMIT INDICATING THAT VERIFICATION OF RESULTS WOULD BE REQUIRED ACCORDING TO THE LABORATORY¿S PROTOCOLS. MULTIPLE INTERPRETIVE MESSAGES WERE GENERATED FOR ALL OF THE SID. THE L5 FLAG WAS GENERATED FOR SID 541932 INDICATING THE POSSIBLE PRESENCE OF IMMATURE CELLS. THE GENERATION OF THIS FLAG INDICATED THAT THE LABORATORY SHOULD FOLLOW THEIR PROTOCOLS FOR INVESTIGATION AND/OR REPORTING OF RESULTS. IT WAS NOTED THAT THE PLT RESULTS ON THE CD EMERALD 22 FOR THESE SAMPLES WERE LOWER THAN THE PLT RESULTS ON CD EMERALD, WHICH THE CUSTOMER CLAIMED WERE CLOSER TO THE ALINITY HQ RESULTS. THE RESULTS ON THE ALINITY HQ FOR THESE SAMPLES WERE NOT PROVIDED. THE RESULTS GENERATED ON CD EMERALD 22 WERE NOT REPORTED. THERE IS FUNDAMENTAL TECHNOLOGY DIFFERENCES BETWEEN THE CD EMERALD 22 AND THE ALINITY HQ TO MEASURE PLT - THE CD EMERALD 22 USES IMPEDANCE TECHNOLOGIES AND ALINITY HQ USES OPTICAL. THE DIFFERENCES IN PLT VALUES ARE NOTICEABLE WHEN THE PLT VALUES ARE ABNORMALLY LOW OR HIGH. IN SUCH CONDITIONS, THE INSTRUMENT USUALLY WOULD FLAG THE SAMPLES AND ALERT CUSTOMERS TO PERFORM A VERIFICATION OF THE RESULTS. BASED ON THE INFORMATION PROVIDED, THE INSTRUMENT PRECISION AND CALIBRATION COULD NOT BE RULED OUT AS THE POTENTIAL CONTRIBUTING FACTORS. ADDITIONALLY, THE DIFFERENCES IN PLT RESULTS BETWEEN THE CD EMERALD 22 AND THE ALINITY HQ, ESPECIALLY WHEN THE PLT VALUES ARE ABNORMALLY HIGH OR LOW, WERE DUE TO THE TECHNOLOGY DIFFERENCES. THE CD EMERALD 22 GENERATED FLAGS INDICATING THAT THE VERIFICATION OF THE RESULTS WAS REQUIRED. PER THE CD EMERALD 22 OPERATOR¿S MANUAL (9141000F¿APRIL 2020), THE CELL-DYN EMERALD 22 HAS BEEN VALIDATED FOR ITS INTENDED USE. HOWEVER, ERROR CAN OCCUR DUE TO POTENTIAL OPERATOR ERRORS AND SYSTEM TECHNOLOGY LIMITATIONS. RESULTS OBTAINED FROM THE SYSTEM SHOULD BE USED WITH OTHER CLINICAL DATA, FOR EXAMPLE, PATIENT SYMPTOMS, OTHER TEST RESULTS, PATIENT HISTORY, CLINICAL IMPRESSIONS, INFORMATION AVAILABLE FROM CLINICAL EVALUATION, AND OTHER DIAGNOSTIC PROCEDURES. LABELING WAS FOUND TO BE ADEQUATE FOR THE COMPLAINT INCIDENT. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE CELL-DYN (CD) EMERALD 22 ANALYZER SERIAL NUMBER (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED PLATELET RESULTS ON CELL-DYN EMERALD ANALYZER FOR ONE ONCOLOGY PATIENTS. THE ONE PATIENT RESULT EXAMPLE PROVIDED ON (B)(6) 2022 WERE: ON (B)(6) 2022 PATIENT B: ON EMERALD=830 K/UL /REPEATED ON ALINITY HQ PROCESSING MODULE=1232 K/UL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2217496 CELL-DYN EMERALD 22 SYSTEM COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 09H5901 00380740020286

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown