BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMUNOGLOBULIN M

    MDR report key: 19070813 · Received April 9, 2024

    Report

    Report Number
    3005094123-2024-00177
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    March 28, 2024
    Report Date
    May 24, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DFT
    UDI-DI
    00380740169916
    PMA / PMN Number
    K983132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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, DEVICE HISTORY RECORD REVIEW AND LABELING REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER CONFIRM THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUES IDENTIFIED. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 60053UD00. TICKET TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT 60053UD00 AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE IMMUNOGLOBULIN M (IGM) REAGENT FOR LOT 60053UD00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    COMPLETED INFORMATION FOR SECTION A1 - PATIENT IDENTIFIER = (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 REPORTED A FALSELY DECREASED IMMUNOGLOBULIN M ON THE ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) INITIAL RUN (STANDARD 1:5 DILUTION) = >16.9 G/L, AUTOMATIC RERUN OF UNDILUTED SAMPLE = 1.045 G/L; RERUN WITH 1:20 MANUAL DILUTION = 40.724 G/L CONFIGURATION OF THE ASSAY IN THE ALINITY C SOFTWARE WAS PERFORMED IN AUGUST 2023. IF THE ANALYZER IS CONFIGURED AS G/L THE RANGE WOULD BE 0-0.25 AND IF CONFIGURED AS MG/DL THE RANGE WOULD BE 0-25. THE UNITS OF MEASURE WERE ENTERED AS G/L, BUT THE RANGE WAS NOT UPDATED TO 0-0.25 G/L. THE ANALYZER CONFIGURATION OF THE RERUN RULE WAS TO PERFORM AN AUTOMATIC RERUN OF AN UNDILUTED SAMPLE IF THE VALUE FELL WITHIN THE RANGE CONFIGURED IN THE SOFTWARE. SINCE THE ALINITY SOFTWARE WAS CONFIGURED WITH A RANGE OF 0-25 G/L, THE AUTOMATIC RERUN PROTOCOL WAS INCORRECT, AND THE SAMPLE WAS REPEATED AS AN UNDILUTED SAMPLE. THE SAMPLE NEEDED TO BE DILUTED PRIOR TO RERUNNING. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY DECREASED IMMUNOGLOBULIN M ON THE ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) - INITIAL RUN (STANDARD 1:5 DILUTION) = >16.9 G/L, AUTOMATIC RERUN OF UNDILUTED SAMPLE = 1.045 G/L; RERUN WITH 1:20 MANUAL DILUTION = 40.724 G/L. CONFIGURATION OF THE ASSAY IN THE ALINITY C SOFTWARE WAS PERFORMED IN AUGUST 2023. IF THE ANALYZER IS CONFIGURED AS G/L THE RANGE WOULD BE 0-0.25 AND IF CONFIGURED AS MG/DL THE RANGE WOULD BE 0-25. THE UNITS OF MEASURE WERE ENTERED AS G/L, BUT THE RANGE WAS NOT UPDATED TO 0-0.25 G/L. THE ANALYZER CONFIGURATION OF THE RERUN RULE WAS TO PERFORM AN AUTOMATIC RERUN OF AN UNDILUTED SAMPLE IF THE VALUE FELL WITHIN THE RANGE CONFIGURED IN THE SOFTWARE. SINCE THE ALINITY SOFTWARE WAS CONFIGURED WITH A RANGE OF 0-25 G/L, THE AUTOMATIC RERUN PROTOCOL WAS INCORRECT, AND THE SAMPLE WAS REPEATED AS AN UNDILUTED SAMPLE. THE SAMPLE NEEDED TO BE DILUTED PRIOR TO RERUNNING. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2423845 IMMUNOGLOBULIN M IGM, ANTIGEN, ANTISERUM, CONTROL DFT ABBOTT IRELAND DIAGNOSTICS DIVISION 60053UD00 00380740169916

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY C PROCESSING MODU, 03R67-01, AC01476| ALNTY C PROCESSING MODU, 03R67-01, AC01476