BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ PROCESSING MODULE

    MDR report key: 18330631 · Received December 14, 2023

    Report

    Report Number
    2919069-2023-00050
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    November 27, 2023
    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
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DATA AND COMPLAINT NOTES DETERMINED THE FOLLOWING SEQUENCE OF ERRORS WAS OBSERVED: 5847-746, 5871-746, 5871-747 AND 5871-808. SERVICE DETAILED ERROR 5871 AXIS ALERT 606 / 10006, BOARD DAMAGED, CONNECTOR SINGED DUE TO OVERHEATING. NO OTHER ISSUES WERE IDENTIFIED. REPLACEMENT OF THE PDU, OR POWER DISTRIBUTION (H-90000047-02), AND GRIPPER CONTROLLER PCB, OR THETA COLLECTION (H-35021642-01), BOARDS RESOLVED THE ISSUE ON THE ALINITY HQ PROCESSING MODULE, SERIAL NUMBER (B)(6). RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THERE IS NO INCREASE IN COMPLAINT ACTIVITY. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY HQ PROCESSING MODULE DID NOT IDENTIFY ANY TRENDS. REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY FOR THE ALINITY HQ PROCESSING MODULE WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

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

    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. UPDATED D4 - PRIMARY UDI NUMBER FROM INITIAL: (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED INSTRUMENT ERROR MESSAGES ON THE ALINITY HQ PROCESSING MODULE. THE ERROR CODES GENERATED WERE 5871 (AXIS ALERT 606 / 10006) AND 5843 (DEVICE FAILED TO INITIALIZE) ON (B)(6) 2023. THE TECHNICAL SERVICE SPECIALIST (TSS) ARRIVED ONSITE TO INSPECT THE INSTRUMENT. THE TSS VERIFIED THAT THE THETA MECHANISM BOARD¿S CONNECTOR AND CABLE SHOWED SIGNS OF CHARRING. ON (B)(6)2203 A SYSTEMS CHECK WAS CARRIED OUT AND FOUND THAT THE ROBOT GRIPPER WAS DAMAGED, CAUSING THE CONNECTOR AND THE BOARD TO BURN. THE SYSTEM WAS CHECKED, AND NO SHORTED CABLES OR LOCKED MOTORS WERE OBSERVED. ON (B)(6) 2023, THE SAMPLE HANDLER ROBOT WAS REPLACED AND THE TSS STILL OBSERVED THE SAME ERROR CODE 5843. THE TSS PERFORMED THE SAMPLER HANDLER ROBOT FIRMWARE PROCEDURE HOWEVER THE ISSUE WAS NOT RESOLVE. THE TSS DISCOVERED THROUGH ADDITIONAL TROUBLESHOOTING THAT THE PDU BOARD WAS DAMAGING THE SAMPLER HANDLER ROBOT GRIPPER, CAUSING THE OVERHEATING AND BURNING OF THE SAMPLER HANDLER ROBOT CABLE AND BOARDS. AS IN THE FIRST ATTEMPT ONLY THE SAMPLER HANDLER ROBOT WAS CHANGED, THE INSTRUMENT¿S PDU BOARD DAMAGED THE NEW GRIPPER, MAKING IT NECESSARY TO REPLACE THE PDU BOARD AND THE SAMPLER HANDLER ROBOT. THERE WAS EVIDENCE OF FIRE OBSERVED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED INSTRUMENT ERROR MESSAGES ON THE ALINITY HQ PROCESSING MODULE. THE ERROR CODES GENERATED WERE 5871 (AXIS ALERT 606 / 10006) AND 5843 (DEVICE FAILED TO INITIALIZE) ON 27NOV2023. THE TECHNICAL SERVICE SPECIALIST (TSS) ARRIVED ONSITE TO INSPECT THE INSTRUMENT. THE TSS VERIFIED THAT THE THETA MECHANISM BOARD¿S CONNECTOR AND CABLE SHOWED SIGNS OF CHARRING. ON 27NOV2203 A SYSTEMS CHECK WAS CARRIED OUT AND FOUND THAT THE ROBOT GRIPPER WAS DAMAGED, CAUSING THE CONNECTOR AND THE BOARD TO BURN. THE SYSTEM WAS CHECKED, AND NO SHORTED CABLES OR LOCKED MOTORS WERE OBSERVED. ON 29NOV2023, THE SAMPLE HANDLER ROBOT WAS REPLACED AND THE TSS STILL OBSERVED THE SAME ERROR CODE 5843. THE TSS PERFORMED THE SAMPLER HANDLER ROBOT FIRMWARE PROCEDURE HOWEVER THE ISSUE WAS NOT RESOLVE. THE TSS DISCOVERED THROUGH ADDITIONAL TROUBLESHOOTING THAT THE PDU BOARD WAS DAMAGING THE SAMPLER HANDLER ROBOT GRIPPER, CAUSING THE OVERHEATING AND BURNING OF THE SAMPLER HANDLER ROBOT CABLE AND BOARDS. AS IN THE FIRST ATTEMPT ONLY THE SAMPLER HANDLER ROBOT WAS CHANGED, THE INSTRUMENT¿S PDU BOARD DAMAGED THE NEW GRIPPER, MAKING IT NECESSARY TO REPLACE THE PDU BOARD AND THE SAMPLER HANDLER ROBOT. THERE WAS EVIDENCE OF FIRE OBSERVED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED INSTRUMENT ERROR MESSAGES ON THE ALINITY HQ PROCESSING MODULE. THE ERROR CODES GENERATED WERE 5871 (AXIS ALERT 606 / 10006) AND 5843 (DEVICE FAILED TO INITIALIZE) ON (B)(6) 2023. THE TECHNICAL SERVICE SPECIALIST (TSS) ARRIVED ONSITE TO INSPECT THE INSTRUMENT. THE TSS VERIFIED THAT THE THETA MECHANISM BOARD¿S CONNECTOR AND CABLE SHOWED SIGNS OF CHARRING. ON (B)(6) 2023 A SYSTEMS CHECK WAS CARRIED OUT AND FOUND THAT THE ROBOT GRIPPER WAS DAMAGED, CAUSING THE CONNECTOR AND THE BOARD TO BURN. THE SYSTEM WAS CHECKED, AND NO SHORTED CABLES OR LOCKED MOTORS WERE OBSERVED. ON (B)(6) 2023, THE SAMPLE HANDLER ROBOT WAS REPLACED AND THE TSS STILL OBSERVED THE SAME ERROR CODE 5843. THE TSS PERFORMED THE SAMPLER HANDLER ROBOT FIRMWARE PROCEDURE HOWEVER THE ISSUE WAS NOT RESOLVE. THE TSS DISCOVERED THROUGH ADDITIONAL TROUBLESHOOTING THAT THE PDU BOARD WAS DAMAGING THE SAMPLER HANDLER ROBOT GRIPPER, CAUSING THE OVERHEATING AND BURNING OF THE SAMPLER HANDLER ROBOT CABLE AND BOARDS. AS IN THE FIRST ATTEMPT ONLY THE SAMPLER HANDLER ROBOT WAS CHANGED, THE INSTRUMENT¿S PDU BOARD DAMAGED THE NEW GRIPPER, MAKING IT NECESSARY TO REPLACE THE PDU BOARD AND THE SAMPLER HANDLER ROBOT. THERE WAS EVIDENCE OF FIRE OBSERVED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447233 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851
    2269093 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown