BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ PROCESSING MODULE

    MDR report key: 18836398 · Received March 5, 2024

    Report

    Report Number
    2919069-2024-00021
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Date of Event
    February 13, 2024
    Report Date
    June 26, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740138851
    PMA / PMN Number
    K220031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    SECTION D4 - PRIMARY UDI NUMBER: THIS SECTION WAS CORRECTED FROM (B)(4). SECTION H4 - DEVICE MFG DATE: UPDATED FROM BLANK TO 8/23/2017. THE COMPLAINT INVESTIGATION INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, AND LABELING REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY HQ PROCESSING MODULE FOR SERIAL (B)(6) WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    CORRECTION WAS MADE TO FIELD D2B PROCODE. THE INCORRECT CODE OF GRZ WAS CHANGED TO GKZ. THIS WAS A TYPOGRAPHICAL ERROR CORRECTION AND THERE IS NO FURTHER IMPACT TO THE SUBMISSION.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED HEMOGLOBIN RESULTS GENERATED ON THE ALINITY HQ PROCESSING MODULE FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 50 G/L (5 G/DL), REPEAT ON ANOTHER ANALYZER = 120 G/L (12 G/DL) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED HEMOGLOBIN RESULTS GENERATED ON THE ALINITY HQ PROCESSING MODULE FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 50 G/L (5 G/DL), REPEAT ON ANOTHER ANALYZER = 120 G/L (12 G/DL) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED HEMOGLOBIN RESULTS GENERATED ON THE ALINITY HQ PROCESSING MODULE FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 50 G/L (5 G/DL), REPEAT ON ANOTHER ANALYZER = 120 G/L (12 G/DL) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1883140 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851
    577859 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown