BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ PROCESSING MODULE

    MDR report key: 18934549 · Received March 19, 2024

    Report

    Report Number
    2919069-2024-00024
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    February 26, 2024
    Report Date
    July 23, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740138851
    PMA / PMN Number
    K220031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE SCATTER IMAGES DETERMINED THE WBC SCATTERS LOOKED OKAY. THE INITIAL RUN HAD VERY FEW EVENTS, AS THE WBC RESULT WAS VERY LOW, AND THE DIFFERENTIAL WAS INVALIDATED DUE TO THE LOW COUNT. THE RE-RUN LOOKED NORMAL. A REVIEW OF THE FCS FILES DETERMINED THE INITIAL RUN HAD VERY FEW EVENTS RESULTING IN LOW WBC COUNT. BASED ON THE INFORMATION PROVIDED, THE CAUSE COULD NOT BE DETERMINED. POTENTIAL REASONS FOR LOW WBC RESULTS COULD NOT RULE OUT INTERMITTENT OBSTRUCTION OR AN INSTRUMENT OR HARDWARE ISSUE (SUCH AS ASPIRATION ISSUE OR CLOT). A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY H-SERIES WBC REAGENT 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 SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY HQ PROCESSING MODULE FOR SERIAL NUMBER (B)(6) OR THE ALINITY H-SERIES WBC REAGENT WAS IDENTIFIED.

    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: FROM (B)(4) TO (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION A1 - PATIENT IDENTIFIER: COMPLETE SID IS (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED WBC RESULT GENERATED ON THE ALINITY HQ ANALYZER FOR A PATIENT. THE RESULT WAS NOT RELEASED OUT OF THE LAB. THE SAMPLE WAS REPEATED AND A HIGHER WBC RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). (B)(6)2024 INITIAL WBC RESULT (B)(4) = 0.176 X 10E3/ L. (B)(6)2024 REPEAT WBC RESULT (B)(4) = 8.50 X 10E3/ L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED WBC RESULT GENERATED ON THE ALINITY HQ ANALYZER FOR A PATIENT. THE RESULT WAS NOT RELEASED OUT OF THE LAB. THE SAMPLE WAS REPEATED AND A HIGHER WBC RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) (B)(6) 2024 INITIAL WBC RESULT (SEQ# (B)(6)) = 0.176 X 10E3/L (B)(6) 2024 REPEAT WBC RESULT (SEQ# (B)(6)) = 8.50 X 10E3/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED WBC RESULT GENERATED ON THE ALINITY HQ ANALYZER FOR A PATIENT. THE RESULT WAS NOT RELEASED OUT OF THE LAB. THE SAMPLE WAS REPEATED AND A HIGHER WBC RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). (B)(6) 2024 INITIAL WBC RESULT (SEQ# (B)(6)) = 0.176 X 10E3/L. (B)(6) 2024 REPEAT WBC RESULT (SEQ# (B)(6)) = 8.50 X 10E3/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1458398 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851
    2554875 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY H WBC REAGENT 975, 07P79-04, UNKNOWN.| ALNTY H WBC REAGENT 975, 07P79-04, UNKNOWN.| ALNTY H WBC REAGENT 975, 07P79-04, UNKNOWN.