BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HS SLIDE MAKER STAINER MODULE

    MDR report key: 20075336 · Received August 27, 2024

    Report

    Report Number
    2919069-2024-00049
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 6, 2024
    Report Date
    October 30, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    KPA
    UDI-DI
    00380740138868
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. THE CUSTOMER PROVIDED FLOW CYTOMETRY STANDARD (FCS) FILES, LOG FILES, SPECIMEN RESULTS, AND IMAGES OF THE SPECIMEN TUBE AND SAMPLE SLIDE WERE SUBMITTED FOR REVIEW. REVIEW OF THE DATA FOUND SEQ 365083 GENERATED A SUSPECT FLAG FOR THE LYM, MONO, AND BASO PARAMETERS. THE SEQUENCE ALSO GENERATED A LEFT SHIFT, VAR LYM, AND BLAST FLAG FOR THE SAMPLE. REVIEW OF THE FCS FILES FOUND THE WBC SCATTER PLOT PATTERNS TO BE ABNORMAL, CONSISTENT WITH THE FLAGGED RESULTS PRODUCED. NO ALGORITHM ISSUES WERE FOUND. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE ALINITY HS PROCESSING MODULE, SERIAL NUMBER (B)(6), WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, 1. PATIENT IDENTIFIER = SID= (B)(6).ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED NO BLAST FOUND FROM CELLAVISION FOR ONE KNOWN BLAST CELL PATIENT ON DIFFERENTIAL PREPARED BY THE ALINITY HS PROCESSING MODULE. THE CBC RESULTS GENERATED FROM ALINITY HQ PROCESSING MODULE WITH BLAST FLAGGING WHICH MATCHED THE PATIENT HISTORY. THE PATHOLOGIST QUESTIONED THE DIFFERENT RESULTS DUE TO NOT SEEN BLAST WITH KNOWN BLAST PATIENT. THE CUSTOMER STATED SMEAR HAS NO BLAST CELL DURING READING FROM CELLAVISION MICROSCOPE. THE CUSTOMER NOTICED SPECIMEN DROPPED INSIDE THE INSTRUMENT. THE ALINITY HS PROCESSING MODULE DID NOT GENERATE ANY FLAG FOR ERROR MESSAGE. THE CUSTOMER MADE MANUAL DIFFERENTIAL AND THAT CONFIRMED BLAST CELLS IN MANUAL PREPARED SMEAR. THE CUSTOMER AGREES WITH MANUAL DIFFERENTIAL RESULTS. THE BARCODE ID IS CORRECT ON SLIDE THAT MADE BY THE ALINITY HS PROCESSING MODULE. THE RESULTS PROVIDED WERE: (B)(6) 2024 SID (B)(6) WBC INITIAL=30.1 10E3/UL; HEMOGLOBIN INITIAL=7.56 G/DL; PLATELET INITIAL=21.2 10E3/UL; DIFFERENTIAL WITH LEFT SHIFT, VAR LYM AND BLAST FLAGS /NO REPEAT RESULTS PROVIDED. CELLAVISION= NO BLAST CELL IDENTIFIED. MANUAL DIFFERENTIAL=BLAST=37 THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED NO BLAST FOUND FROM CELLAVISION FOR ONE KNOWN BLAST CELL PATIENT ON DIFFERENTIAL PREPARED BY THE ALINITY HS PROCESSING MODULE. THE CBC RESULTS GENERATED FROM ALINITY HQ PROCESSING MODULE WITH BLAST FLAGGING WHICH MATCHED THE PATIENT HISTORY. THE PATHOLOGIST QUESTIONED THE DIFFERENT RESULTS DUE TO NOT SEEN BLAST WITH KNOWN BLAST PATIENT. THE CUSTOMER STATED SMEAR HAS NO BLAST CELL DURING READING FROM CELLAVISION MICROSCOPE. THE CUSTOMER NOTICED SPECIMEN DROPPED INSIDE THE INSTRUMENT. THE ALINITY HS PROCESSING MODULE DID NOT GENERATE ANY FLAG FOR ERROR MESSAGE. THE CUSTOMER MADE MANUAL DIFFERENTIAL AND THAT CONFIRMED BLAST CELLS IN MANUAL PREPARED SMEAR. THE CUSTOMER AGREES WITH MANUAL DIFFERENTIAL RESULTS. THE BARCODE ID IS CORRECT ON SLIDE THAT MADE BY THE ALINITY HS PROCESSING MODULE. THE RESULTS PROVIDED WERE: (B)(6) 2024 SID (B)(6) WBC INITIAL=30.1 10E3/UL; HEMOGLOBIN INITIAL=7.56 G/DL; PLATELET INITIAL=21.2 10E3/UL; DIFFERENTIAL WITH LEFT SHIFT, VAR LYM AND BLAST FLAGS /NO REPEAT RESULTS PROVIDED. CELLAVISION= NO BLAST CELL IDENTIFIED. MANUAL DIFFERENTIAL=BLAST=37 THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29457 ALINITY HS SLIDE MAKER STAINER MODULE SLIDE STAINER, AUTOMATED KPA ABBOTT LABORATORIES 00380740138868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown