BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIO AUTOMATION

    MDR report key: 14394612 · Received May 13, 2022

    Report

    Report Number
    3010825766-2022-00002
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Report Date
    September 19, 2022
    Manufacturer
    INPECO SA
    Product Code
    CEM
    UDI-DI
    07640172342008
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER IS USING CODABAR BARCODE SYMBOLOGY WITHOUT CHECK DIGIT AND THE RANGE IS CONFIGURED FROM 2 DIGITS TO 23 DIGITS. BASED ON THE PROVIDED INFORMATION THE SID MISREADS OCCUR ONLY ON UNCAPPED SAMPLE TUBES RECEIVED FROM A SPECIFIC BLOOD COLLECTION CENTER. THE EVENT IS CURRENTLY UNDER INVESTIGATION TO DETERMINE IF THE QUALITY OF THE LABEL IS COMPATIBLE WITH THE MINIMUM PRINT QUALITY REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT (MDR 3010825766-2022-00002) WAS SUBMITTED ON MAY 13TH, 2022. ADDITIONAL INFORMATION: THE DISTRIBUTOR SENT TO INPECO SOME EXAMPLES OF TUBE LABELS TO ASSESS THE PRINT QUALITY. THE ANALYSIS SHOWED THAT SOME OF THE PROVIDED LABELS (12,5%) WERE NOT COMPATIBLE WITH THE MINIMUM PRINT QUALITY REQUIREMENTS. THE POOR LABEL QUALITY MAY AFFECT THE SAMPLE ID READINGS AT THE TUBE IDENTIFICATION MODULES AND IT MAY LEAD TO A SID MISREADING. WITH THE PROVIDED DATA IT HAS NOT BEEN POSSIBLE TO IDENTIFY OTHER CAUSES. INPECO SUGGESTED THE CUSTOMER TO UPGRADE THE TUBE IDENTIFICATION MODULE FIRMWARE TO THE LAST VERSION IN WHICH ISSUES OF SAMPLE ID NOT READ (NOT STRICTLY RELATED TO THE SCENARIO REPORTED FROM THE FIELD) WERE IMPROVED. INPECO OFFERED ASSISTANCE TO CORRECTLY CALIBRATE THE CAMERA.

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT (MDR 3010825766-2022-00002 ) WAS SUBMITTED ON MAY 13TH, 2022. REFERRING TO THE SUPPLEMENTAL REPORT (MDR 3010825766-2022-00002 S1) SUBMITTED ON AUG. 4TH, 2022, THE ACTUAL PERCENTAGE OF LABEL NOT COMPATIBLE WITH THE MINIMUM PRINT QUALITY REQUIREMENTS IS 7.5% INSTEAD OF 12.5% PREVIOUSLY COMMUNICATED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SEVERAL CASES OF MISREAD SAMPLE TUBE IDS (SIDS) ON THE TUBE IDENTIFICATION MODULES AT THE INPUT MODULES. IN CASE THE MISREAD SID BELONGS TO A SAMPLE TUBE (TUBE B) WHICH IS EXPECTED TO BE LOADED ON THE AUTOMATION SYSTEM AND HAS PENDING TEST ORDERS, THE WRONGLY IDENTIFIED SAMPLE TUBE (TUBE A) IS TESTED ACCORDING TO THE ORDERS RECEIVED FOR TUBE B. IF THE SAMPLE TUBES IS SENT TO A MODULE OR TO A THIRD PARTY ANALYZER WHICH CHECKS THE SAMPLE ID THE SAMPLE TUBE IS FLAGGED WITH SAMPLE ID MISMATCH ERROR AND IT IS SENT TO THE INPUT/OUTPUT MODULE. OTHERWISE, IF THE TESTS ARE EXECUTED BY AN ANALYZER WHICH DO NOT READ THE SID, THE MISMATCH ERROR IS NOT DETECTED AND THE TEST RESULTS ARE ASSOCIATED TO THE WRONG PATIENT. WHEN THE SAMPLE TUBE B IS ACTUALLY LOADED ON THE AUTOMATION SYSTEM IT IS FLAGGED WITH ERROR SC00E "DUPLICATE SAMPLE ID" AND UNLOADED INTO THE PRIORITY OUTPUT RACK OF THE INPUT OUTPUT MODULE TO BE MANUALLY HANDLED BY THE OPERATORS. NO CASES OF ACTUAL ERRONEOUS RESULTS NOR IMPACTS ON PATIENT CARE HAVE BEEN REPORTED FROM THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2312459 APTIO AUTOMATION LABORATORY AUTOMATION SYSTEM CEM INPECO SA AP2 07640172342008

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown