BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINIQ AMS

    MDR report key: 19723818 · Received July 11, 2024

    Report

    Report Number
    3004032053-2024-00011
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    June 25, 2024
    Report Date
    August 22, 2024
    Manufacturer
    ABBOTT SRL
    Product Code
    JQP
    UDI-DI
    00380740202736
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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

    SECTION B5 WAS UPDATED WITH: ADDITIONAL DATA PROVIDED ON 13AUG2024: CUSTOMER STATES TOTAL OF 5 PATIENTS IMPACTED. THREE PATIENT RESULTS SHOULD HAVE BEEN <0.25 G/L AND THE LIS RELEASED 0.25 G/L. ONE PATIENT RESULT WAS 0.258 G/L AND LIS RELEASED 0.25 G/L NO CORRECTION NEEDED. THE FIFTH SAMPLE WAS DISPOSED OF AND NOT REPEATED. THE COMPLAINT INVESTIGATION INDICATED THAT THE CAUSE OF THE ISSUE WAS AN INCORRECT CONFIGURATION SETUP. THE ISSUE WAS CORRECTED. A REVIEW OF COMPLAINTS FOR THIS ISSUE WAS PERFORMED AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED. A REVIEW OF HISTORICAL DATA REVEALED NO TRENDS, SYSTEMIC ISSUES, OR RELATED NONCONFORMANCES FOR THE COMPLAINT ISSUE. CURRENT LABELLING CONTAINED ADEQUATE INFORMATION REGARDING THE CONFIGURATION OF DILUTION FACTORS AND EXPECTED BEHAVIOR OF THE MIDDLEWARE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT¿S COMPLAINT INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINIQ AMS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A RETEST WAS PERFORMED FOR THE S-IGA ASSAY WITH A STD 1:5 DILUTION WHEN IT SHOULD HAVE PROCESSED THE SAMPLE UNDILUTED. THE CAUSE WAS THE AMS SOFTWARE WAS CONFIGURED INCORRECTLY TO RUN AS 1:UNDILUTED, RERUN WITHOUT A DILUTION FACTOR SO THE INSTRUMENT RAN THE SAMPLE WITH THE STANDARD 1:5 DILUTION AS THIS IS THE DEFAULT FOR THIS ASSAY. DUE TO THE DILUTION THE RESULT WAS REPORTED BY AMS WAS <0.250 AND THE LIS REMOVED THE < CHARACTER AND RELEASED 0.250. THE CORRECT RESULT WAS <0.050. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A RETEST WAS PERFORMED FOR THE S-IGA ASSAY WITH A STD 1:5 DILUTION WHEN IT SHOULD HAVE PROCESSED THE SAMPLE UNDILUTED. THE CAUSE WAS THE AMS SOFTWARE WAS CONFIGURED INCORRECTLY TO RUN AS 1: UNDILUTED, RERUN WITHOUT A DILUTION FACTOR SO THE INSTRUMENT RAN THE SAMPLE WITH THE STANDARD 1:5 DILUTION AS THIS IS THE DEFAULT FOR THIS ASSAY. DUE TO THE DILUTION THE RESULT WAS REPORTED BY AMS WAS <0.250 AND THE LIS REMOVED THE < CHARACTER AND RELEASED 0.250. THE CORRECT RESULT WAS <0.050. ADDITIONAL DATA PROVIDED ON 13AUG2024: CUSTOMER STATES TOTAL OF 5 PATIENTS IMPACTED. THREE PATIENT RESULTS SHOULD HAVE BEEN <0.25 G/L AND THE LIS RELEASED 0.25 G/L. ONE PATIENT RESULT WAS 0.258 G/L AND LIS RELEASED 0.25 G/L NO CORRECTION NEEDED. THE FIFTH SAMPLE WAS DISPOSED OF AND NOT REPEATED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314735 ALINIQ AMS CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT SRL 00380740202736

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown