BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ PROCESSING MODULE

    MDR report key: 18607846 · Received January 30, 2024

    Report

    Report Number
    2919069-2024-00012
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Date of Event
    January 12, 2024
    Report Date
    July 1, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740138851
    PMA / PMN Number
    K220031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 GKZ. THIS WAS A TYPOGRAPHICAL ERROR CORRECTION AND THERE IS NO FURTHER IMPACT TO THE SUBMISSION.

    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

    SCATTERPLOT IMAGES AND MANUAL RESULTS FOR PLT WERE SUBMITTED BY THE CUSTOMER. THE BASO RESULTS PRESENTED IN THIS TICKET WERE ALL WITHIN THE TYPICAL NORMAL RANGE. THE SHIFT OF BASO COULD NOT BE CHARACTERIZED BY THE DATA PRESENTED. RDW BASELINE WAS NOT PROVIDED SO RDW SHIFT COULD NOT BE DETERMINED. THE PLT RESULTS IN THE TABLE SHOWED DISCREPANCIES IN PLT RESULTS BETWEEN THE ALINITY HQ AND MANUAL COUNT. THE REVIEW OF THE SMEARS DID NOT IDENTIFY ANY PLT CLUMPS NOR ANY LARGE PLTS. RBCS APPEARED FLAT WITHOUT TYPICAL BICONCAVE SHAPE. TARGET CELLS WERE SPOTTED. A REVIEW OF ALL COMPLAINTS ASSOCIATED WITH THE ALINITY HQ (LIST NUMBER 09P68-01) AND A REVIEW OF COMPLAINT TRENDS FOR THE LIST NUMBER WAS PERFORMED. THE REVIEW DID NOT IDENTIFY ANY TRENDS OR ABNORMAL COMPLAINT ACTIVITY. ADDITIONALLY, LABELING WAS REVIEWED AND ADEQUATELY ADDRESSED THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED PLATELET RESULTS GENERATED ON THE ALINITY HQ PROCESSING MODULE. THE CUSTOMER STATED THAT SINCE UPDATING TO VERSION 5.0 SOFTWARE, THE ALINITY HQ PROCESSING MODULE HAS HAD A PROBLEM READING MACRO PLATELETS AND PLATELET AGGREGATES. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) PLT RESULT INSTRUMENT: 11.6, MANUAL PLATELET COUNT 63. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED PLATELET RESULTS GENERATED ON THE ALINITY HQ PROCESSING MODULE. THE CUSTOMER STATED THAT SINCE UPDATING TO VERSION 5.0 SOFTWARE, THE ALINITY HQ PROCESSING MODULE HAS HAD A PROBLEM READING MACRO PLATELETS AND PLATELET AGGREGATES. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) PLT RESULT INSTRUMENT: 11.6, MANUAL PLATELET COUNT 63. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2192754 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851
    2547971 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown