BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ PROCESSING MODULE

    MDR report key: 19097087 · Received April 12, 2024

    Report

    Report Number
    2919069-2024-00025
    Event Type
    Malfunction
    Date Received
    April 12, 2024
    Date of Event
    March 22, 2024
    Report Date
    August 8, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740138851
    PMA / PMN Number
    K220031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION WAS MADE TO FIELD D2B PRO CODE. THE INCORRECT CODE OF GRZ WAS CHANGED TO CORRECT CODE GKZ. THIS WAS A TYPOGRAPHICAL ERROR CORRECTION. UPDATED INFORMATION IN SECTION D4 PRIMARY UDI NUMBER TO (B)(4) 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. REVIEW OF THE FCS FILES FOR SEQ 27394, SEQ 27597, AND SEQ 27599 INDICATED THAT THE ALGORITHM DETECTED THE PRESENCE OF A PLT CLUMP-LIKE POPULATION, BUT IT WAS NOT IN THE TYPICAL PLT CLUMP LOCATION; THUS, THE PLT CLUMP FLAGGING WAS NOT TRIGGERED. THE PLT CLUMP FLAG WAS TRIGGERED FOR SEQ 27598 BECAUSE THE ALGORITHM DETECTED POTENTIAL OVERLAPPING OF THE PLT CLUMP-LIKE POPULATION WITH THE NEUTROPHILS. THE SMEAR IMAGES WERE NOT CLEAR. HUGE PLT CLUMPS/CLUSTERS WERE SEEN LIKELY IN THE FEATHER EDGE OF THE SMEARS. IT WAS NOTED IN THE TICKET "THE SAMPLE EXHIBITED VISIBLE FIBRIN DEPOSITS AND PLATELET AGGREGATION." IT IS UNCLEAR WHETHER IT IMPLIED VISIBLE CLOTTING WAS OBSERVED. PRE-ANALYTICAL FACTORS COULD NOT BE RULED OUT. BASED ON THE INFORMATION PROVIDED, THE ISSUE MIGHT BE RELATED TO THE SPECIFIC SAMPLE PATHOLOGY. PRE-ANALYTICAL FACTORS COULD NOT BE RULED OUT. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE ALINITY HQ 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). 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 ABSENCE OF PLATELET CLUMP FLAGGING ON LOW PLATELET RESULTS GENERATED FROM ALINITY HQ PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2024 SID (B)(6) INITIAL ON ALINITY HQ01108=5.23 NO FLAG FOR PLATELET CLUMPS /PREVIOUS HISTORY=20.0 /REPEATED ON ALINITY HQ01116=9.51 AND 18.9 /REPEATED=14.5 WITH INVALID FLAG; THERE IS PLATELET CLUMPING FOR MICROSCOPIC EXAMINATION. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED ABSENCE OF PLATELET CLUMP FLAGGING ON LOW PLATELET RESULTS GENERATED FROM ALINITY HQ PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2024 SID (B)(6) INITIAL ON ALINITY HQ01108=5.23 NO FLAG FOR PLATELET CLUMPS /PREVIOUS HISTORY=20.0 /REPEATED ON ALINITY HQ01116=9.51 AND 18.9 /REPEATED=14.5 WITH INVALID FLAG; THERE IS PLATELET CLUMPING FOR MICROSCOPIC EXAMINATION. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327770 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851
    793938 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown