BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD 22 SYSTEM

    MDR report key: 20262970 · Received September 19, 2024

    Report

    Report Number
    2919069-2024-00053
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    September 8, 2024
    Report Date
    November 21, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740020286
    PMA / PMN Number
    K110381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CELL-DYN EMERALD, SERIAL NUMBER (B)(6) WAS EVALUATED. REPLACEMENT OF THE MOTOR AND SAMPLING ASSEMBLY ADDRESSED THE EMERGENCY STOP ISSUE. THE DILUENT WAS THEN REPLACED AS IT WAS NOTED TO BE LOW, AND AFTER MULTIPLE PRIMES/FLUSHES THE ISSUE WAS RESOLVED. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY A TREND WITH REGARDS TO THE CUSTOMER REPORTED EVENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES FOR THE CELL-DYN EMERALD AS IT RELATES TO THE CUSTOMER REPORTED EVENT. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED ISSUE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.

    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

    ADDITIONAL INFORMATION RECEIVED AND A1 AND B5 HAS BEEN UPDATED. SECTION A1: PATIENT IDENTIFIER - COMPLETE LIST OF PATIENT SAMPLE ID'S ARE (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED PLATELET GENERATED FROM A CELL-DYN EMERALD AND PROVIDED THE FOLLOWING DATA FOR 2 PATIENTS: CUSTOMER NORMAL PLATELET RANGE 140-442 K/L. PATIENT 1 INITIAL RESULT WAS 1052 AND REPEAT RESULT WAS 268. PATIENT 2 INITIAL RESULT WAS 942 AND REPEAT RESULT WAS 322. CUSTOMER ALSO REPORTED THAT THEY DID NOT REPORT OUT THE INITIAL RESULTS, BUT RATHER THE REPEAT RESULTS. CUSTOMER ALSO STATES INTERMITTENTLY GETTING EMERGENCY STOP AND NOTE THE ANALYZER IS REBOOTED WHICH HELPS WITH RESOLUTION. IT WAS REPORTED THAT FURTHER TROUBLESHOOTING WAS PERFORMED, WHICH INCLUDED REPLACEMENT OF ANALYZER PARTS AND A SAMPLE WAS TESTED AND GENERATED PLATELET RESULTS WHICH WERE SIMILAR TO THE RECORDED RESULT OF THE SAMPLE. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. ADDITIONAL INFORMATION RECEIVED. THE CUSTOMER PROVIDED FURTHER DETAILS FOR PATIENT 1 AND 2 SAMPLES. PATIENT 1 SAMPLE ID WAS (B)(6) AND ON (B)(6) 2024 THE INITIAL PLATELET RESULT WAS 1083 AND REPEAT RESULT WAS 268 PATIENT 1 SAMPLE ID WAS (B)(6) AND ON (B)(6) 2024 THE INITIAL PLATELET RESULT WAS 942 AND REPEAT RESULT WAS 322.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED PLATELET GENERATED FROM A CELL-DYN EMERALD AND PROVIDED THE FOLLOWING DATA FOR 2 PATIENTS: CUSTOMER NORMAL PLATELET RANGE 140-442 K/¿L: PATIENT 1 INITIAL RESULT WAS 1052 AND REPEAT RESULT WAS 268. PATIENT 2 INITIAL RESULT WAS 942 AND REPEAT RESULT WAS 322. CUSTOMER ALSO REPORTED THAT THEY DID NOT REPORT OUT THE INITIAL RESULTS, BUT RATHER THE REPEAT RESULTS. CUSTOMER ALSO STATES INTERMITTENTLY GETTING EMERGENCY STOP AND NOTE THE ANALYZER IS REBOOTED WHICH HELPS WITH RESOLUTION. IT WAS REPORTED THAT FURTHER TROUBLESHOOTING WAS PERFORMED, WHICH INCLUDED REPLACEMENT OF ANALYZER PARTS AND A SAMPLE WAS TESTED AND GENERATED PLATELET RESULTS WHICH WERE SIMILAR TO THE RECORDED RESULT OF THE SAMPLE. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED PLATELET GENERATED FROM A CELL-DYN EMERALD AND PROVIDED THE FOLLOWING DATA FOR 2 PATIENTS: CUSTOMER NORMAL PLATELET RANGE 140-442 K/L. PATIENT 1 INITIAL RESULT WAS 1052 AND REPEAT RESULT WAS 268. PATIENT 2 INITIAL RESULT WAS 942 AND REPEAT RESULT WAS 322. CUSTOMER ALSO REPORTED THAT THEY DID NOT REPORT OUT THE INITIAL RESULTS, BUT RATHER THE REPEAT RESULTS. CUSTOMER ALSO STATES INTERMITTENTLY GETTING EMERGENCY STOP AND NOTE THE ANALYZER IS REBOOTED WHICH HELPS WITH RESOLUTION. IT WAS REPORTED THAT FURTHER TROUBLESHOOTING WAS PERFORMED, WHICH INCLUDED REPLACEMENT OF ANALYZER PARTS AND A SAMPLE WAS TESTED AND GENERATED PLATELET RESULTS WHICH WERE SIMILAR TO THE RECORDED RESULT OF THE SAMPLE. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. ADDITIONAL INFORMATION RECEIVED. THE CUSTOMER PROVIDED FURTHER DETAILS FOR PATIENT 1 AND 2 SAMPLES. PATIENT 1 SAMPLE ID WAS (B)(6) AND ON (B)(6) 2024 THE INITIAL PLATELET RESULT WAS 1083 AND REPEAT RESULT WAS 268. PATIENT 1 SAMPLE ID WAS (B)(6) AND ON (B)(6) 2024 THE INITIAL PLATELET RESULT WAS 942 AND REPEAT RESULT WAS 322.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2296563 CELL-DYN EMERALD 22 SYSTEM COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740020286

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CD EMRLD 22 DIL, 09H62-01, UNKNOWN| CD EMRLD 22 DIL, 09H62-01, UNKNOWN| CD EMRLD 22 DIL, 09H62-01, UNKNOWN