BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ PROCESSING MODULE

    MDR report key: 19267141 · Received May 8, 2024

    Report

    Report Number
    2919069-2024-00031
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Date of Event
    April 19, 2024
    Report Date
    September 11, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740138851
    PMA / PMN Number
    K220031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    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

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND FOUND A VALVE IN THE PNEUMATICS SUBSYSTEM WAS CLOGGED AND ATMOSPHERIC WASTE WAS NOT DRAINING PROPERLY. THE FSR REPLACED THE CLOGGED VALVE TO RESOLVE THE ISSUE. A REVIEW OF TRACKING AND TRENDING OF THE PRODUCT LIST NUMBER AND COMPLAINT ACTIVITY DID NOT IDENTIFY ANY TRENDS FOR THE ALINITY HQ INSTRUMENT WITH REGARDS TO THE CURRENT ISSUE. THE DEVICE HISTORY RECORDS WERE REVIEWED, AND NO NON-CONFORMANCES WERE IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE CUSTOMER SUBMITTED FLOW CYTOMETRY STANDARD (FCS) FILES, AND PRINT SCREENS OF THE PATIENT RESULTS. REVIEW OF THE FCS FILES CONFIRMED THE RBC RAW COUNT AND DERIVED MEASURANDS (HCT) SHOWED SAMPLE DISCREPANCY, POSSIBLY DUE TO SHORT SAMPLE OR OTHER HARDWARE ISSUE. THE HGB DETECTOR IS INDEPENDENT OF RBC OPTIC MEASUREMENT, YET HGB AND CHGB TRACKED SIMILARLY, FURTHER SUPPORTING THE CAUSE OF THE COMPLAINT ISSUE DUE TO HARDWARE, RATHER THAN SOFTWARE ALGORITHM. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY HQ PROCESSING MODULE SERIAL NUMBER (B)(6) WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED HEMOGLOBIN RESULT GENERATED ON THE ALINITY HQ ANALYZER FOR A 73-YEAR-OLD FEMALE PATIENT. THE RESULT WAS NOT CONSISTENT WITH THE PATIENT¿S HISTORY. THE SAMPLE WAS REPEATED AND HIGHER RESULTS WERE OBTAINED WHICH WERE CONSISTENT WITH THE PATIENT¿S HISTORY. THE FOLLOWING DATA WAS PROVIDED: 19APR2024 SID (B)(6) SEQ#535689 (HQ00483) INITIAL HGB RESULT = 7.69 G/DL 19APR2024 SID (B)(6) SEQ#535987 (HQ00483) REPEAT HGB RESULT = 11.7 G/DL (B)(6) 2024 SID (B)(6) SEQ#536001 (HQ00481) REPEAT HGB RESULT = 11.8 G/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED HEMOGLOBIN RESULT GENERATED ON THE ALINITY HQ ANALYZER FOR A 73-YEAR-OLD FEMALE PATIENT. THE RESULT WAS NOT CONSISTENT WITH THE PATIENT¿S HISTORY. THE SAMPLE WAS REPEATED AND HIGHER RESULTS WERE OBTAINED WHICH WERE CONSISTENT WITH THE PATIENT¿S HISTORY. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024 SID (B)(6). SEQ#535689 (HQ00483) INITIAL HGB RESULT = 7.69 G/DL. (B)(6) 2024 SID (B)(6). SEQ#535987 (HQ00483) REPEAT HGB RESULT = 11.7 G/DL. (B)(6) 2024 SID (B)(6). SEQ#536001 (HQ00481) REPEAT HGB RESULT = 11.8 G/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1458402 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851
    99657 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female