BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ PROCESSING MODULE

    MDR report key: 19266933 · Received May 8, 2024

    Report

    Report Number
    2919069-2024-00030
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Date of Event
    April 15, 2024
    Report Date
    September 7, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740138851
    PMA / PMN Number
    K220031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. FLOW CYTOMETRY STANDARD (FCS) FILES AND PRINT SCREENS WERE PROVIDED BY THE CUSTOMER. A REVIEW OF THE FCS FILES SHOWED A BIG CLUSTER OF HIGH FLUORESCENT SMALL LYMPHOCYTES (LYM) LOCATED IN THE REGION WHERE NRBC WAS MEASURED, RESULTING IN LYM BEING MISCLASSIFIED AS NRBC. THE CUSTOMER STATED THAT SMALL LYMPHOCYTES WERE FOUND IN THE MANUAL SMEAR VIEWS, BUT THERE WERE NO NRBC. SMEAR IMAGES WERE NOT PROVIDED. PATIENT DISEASE CONDITION IS UNKNOWN. BASED ON THE INFORMATION PROVIDED, THE ISSUE MIGHT BE RELATED TO THE SPECIFIC SAMPLE PATHOLOGY. THE WBC AND/OR WBC DIFFERENTIAL RESULTS WERE INVALIDATED, INDICATING THE VERIFICATION THE RESULTS WAS REQUIRED. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY H-SERIES 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) WAS IDENTIFIED.

    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

    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.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED WBC RESULTS GENERATED ON THE ALINITY HQ ANALYZER FOR A 73-YEAR-OLD FEMALE PATIENT. THE RESULTS DID NOT MATCH THE PATIENT¿S PREVIOUS RESULTS AND THEREFORE WERE NOT RELEASED OUT OF THE LAB. THE SAMPLE WAS TESTED ON A NON-ABBOTT INSTRUMENT AND THE RESULT WAS HIGHER. A SLIDE REVIEW OF THE SAMPLE SHOWED MANY SMALL LYMPHOCYTES AND NO NUCLEATED RBCS. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024 SID (B)(6). SEQ#(B)(6) ¿ INITIAL RESULT. WBC = 12.3 X 10E9/L -INVALID DATA, MARKED WITH AN X. (B)(6) 2024 SID (B)(6). SEQ#(B)(6) ¿ REPEAT #1. WBC = 13.6 X 10E9/L -INVALID DATA, MARKED WITH X. (B)(6) 2024 SID (B)(6). SEQ#(B)(6) ¿ REPEAT #2 WBC = 13.4 X 10E9/L. (B)(6) 2024 SID (B)(6). SEQ#(B)(6)- REPEAT #3. WBC = 12.8 X 10E9/L. NON-ABBOTT INSTRUMENT: WBC = 148.2 X 10E9/L (REFERENCE RANGE 4.5 TO 11.0). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED WBC RESULTS GENERATED ON THE ALINITY HQ ANALYZER FOR A 73-YEAR-OLD FEMALE PATIENT. THE RESULTS DID NOT MATCH THE PATIENT¿S PREVIOUS RESULTS AND THEREFORE WERE NOT RELEASED OUT OF THE LAB. THE SAMPLE WAS TESTED ON A NON-ABBOTT INSTRUMENT AND THE RESULT WAS HIGHER. A SLIDE REVIEW OF THE SAMPLE SHOWED MANY SMALL LYMPHOCYTES AND NO NUCLEATED RBCS. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024 SID (B)(6). SEQ#368975 ¿ INITIAL RESULT WBC = 12.3 X 10E9/L -INVALID DATA, MARKED WITH AN X (B)(6) 2024 SID (B)(6) SEQ#368994 ¿ REPEAT #1 WBC = 13.6 X 10E9/L -INVALID DATA, MARKED WITH X (B)(6) 2024 SID (B)(6) SEQ#369087 ¿ REPEAT #2 WBC = 13.4 X 10E9/L (B)(6) 2024 SID (B)(6) SEQ#369091- REPEAT #3 WBC = 12.8 X 10E9/L NON-ABBOTT INSTRUMENT: WBC = 148.2 X 10E9/L (REFERENCE RANGE 4.5 TO 11.0) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123283 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851
    1458401 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female