BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ PROCESSING MODULE

    MDR report key: 18773289 · Received February 23, 2024

    Report

    Report Number
    2919069-2024-00019
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    February 7, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4 - PRIMARY UDI NUMBER: THIS SECTION WAS CORRECTED FROM (B)(4). SECTION D10 - CONCOMITANT PRODUCT SECTION UPDATED. INVESTIGATION WAS DONE BY THE ON-SITE ENGINEER (SYSTEMS ENGINEERING) WHO DETERMINED PART H-35013003-01, FFC XYZT TO X-COLLECTOR, TO BE THE LIKELY CAUSE OF THE SHORTING AND SMOKING. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY HQ PROCESSING MODULE, SERIAL NUMBER (B)(6), WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    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 THAT SHORTLY AFTER POWERING ON THE ALINITY HQ PROCESSING MODULE AND DURING LUI SOFTWARE INSTALL, VISIBLE SMOKE WAS SEEN COMING OUT OF THE RIGHT SIDE OF THE ANALYZER. THE POWER WAS IMMEDIATELY SHUT OFF TO THE SYSTEM, AND THE SMOKE APPEARED TO BE COMING FROM THE TUBE ROBOT ASSEMBLY. NO CHARRED OR BLACKENED COMPONENTS HAVE BEEN OBSERVED ON THE ANALYZER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO INJURY TO THE USER WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED THAT SHORTLY AFTER POWERING ON THE ALINITY HQ PROCESSING MODULE AND DURING LUI SOFTWARE INSTALL, VISIBLE SMOKE WAS SEEN COMING OUT OF THE RIGHT SIDE OF THE ANALYZER. THE POWER WAS IMMEDIATELY SHUT OFF TO THE SYSTEM, AND THE SMOKE APPEARED TO BE COMING FROM THE TUBE ROBOT ASSEMBLY. NO CHARRED OR BLACKENED COMPONENTS HAVE BEEN OBSERVED ON THE ANALYZER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO INJURY TO THE USER WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED THAT SHORTLY AFTER POWERING ON THE ALINITY HQ PROCESSING MODULE AND DURING LUI SOFTWARE INSTALL, VISIBLE SMOKE WAS SEEN COMING OUT OF THE RIGHT SIDE OF THE ANALYZER. THE POWER WAS IMMEDIATELY SHUT OFF TO THE SYSTEM, AND THE SMOKE APPEARED TO BE COMING FROM THE TUBE ROBOT ASSEMBLY. NO CHARRED OR BLACKENED COMPONENTS HAVE BEEN OBSERVED ON THE ANALYZER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO INJURY TO THE USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228397 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851
    577858 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALINITY H-SERIES TUBE HANDLING ROBOT, H-35007644-1.| FFC XYZT TO X-COLLECTOR, H-35013003-01, UNKNOWN.| FFC XYZT TO X-COLLECTOR, H-35013003-01, UNKNOWN.