BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLP ALIQUOT MODULE

    MDR report key: 22689395 · Received August 1, 2025

    Report

    Report Number
    3023268435-2025-00011
    Event Type
    Malfunction
    Date Received
    August 1, 2025
    Date of Event
    July 14, 2025
    Report Date
    August 25, 2025
    Manufacturer
    ABBOTT AUTOMATION SOLUTIONS GMBH
    Product Code
    JQP
    UDI-DI
    00380740186821
    PMA / PMN Number
    K213486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A1 - PATIENT IDENTIFIER: SAMPLE IDS = (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, GLP ALIQUOT MODULE, LIST NUMBER 06Q12-01, WHICH HAS A SAME/SIMILAR COMPONENT OF THE MODULAR GLP SYSTEMS TRACK REGISTERED IN THE US, LIST NUMBER 04Z96, WITH 510K NUMBER K213486. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION D10 - CONCOMITANT PRODUCT: ALIQUOT PRINTER WAS ADDED. THE ABBOTT AUTOMATION SOLUTIONS (AAS) TECHNICAL GROUP PERFORMED AN INVESTIGATION BASED ON THE COMPLAINT INFORMATION. THE AAS TEAM IDENTIFIED THAT BARCODE INFORMATION FOR PATIENT A WAS LABELED WITH THE IDENTIFICATION NAME FROM A SECONDARY SAMPLE, PATIENT B. IT WAS ALSO OBSERVED THAT THE PRINTING HEAD HAD GREEN RESIDUE, WHICH ORIGINATED FROM THE RUBBER ROLLER. THE AAS TEAM ANALYZED THE IMAGES OF THE DAMAGED LABEL AND THE LABEL LAYOUT, WHERE A PORTION OF THE DAMAGED LABEL WAS SHOWN TO HAVE BEEN CUT AND GLUED TO THE NEXT TUBE. THIS WAS CAUSED BY THE WORN RUBBER ROLLERS. DUE TO THIS, THE ALIQUOT PRINTER WAS REPLACED, AND FIRMWARE WAS UPGRADED. THE ISSUE DID NOT RETURN. A REVIEW OF COMPLAINT AND TRENDING DATA FOR THE GLP ALIQUOT MODULE AND THE ALIQUOT PRINTER DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO NON-CONFORMANCES OR DEVIATIONS WERE IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY FOR THE GLP ALIQUOT MODULE, SERIAL NUMBER (B)(6), OR THE ALIQUOT PRINTER WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE GLP ALIQUOT MODULE INCORRECTLY LABELED SECONDARY TUBES WITH THE WRONG PATIENT NAMES FOR TWO SEPARATE CASES: PATIENT 1: SID: (B)(6). CORRECT NAME: S.B. THE SECONDARY TUBE WAS LABELED WITH THE NAME M.L., WHO IS ASSOCIATED WITH SID 0211436707. PATIENT 2: SID: (B)(6) CORRECT NAME: D.M. THE SECONDARY TUBE WAS LABELED WITH THE NAME K.T., WHO IS ASSOCIATED WITH SID (B)(6). THERE WAS NO TEST ORDERED FOR THE ALIQUOT TUBE WITH SID 0211150782. IT WAS CONFIRMED THAT THE AFFECTED SAMPLES DID NOT LEAVE THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE GLP ALIQUOT MODULE INCORRECTLY LABELED SECONDARY TUBES WITH THE WRONG PATIENT NAMES FOR TWO SEPARATE CASES: PATIENT 1: SID: (B)(6), CORRECT NAME: (B)(6), THE SECONDARY TUBE WAS LABELED WITH THE NAME (B)(6), WHO IS ASSOCIATED WITH SID (B)(6). PATIENT 2: SID: (B)(6), CORRECT NAME: (B)(6), THE SECONDARY TUBE WAS LABELED WITH THE NAME (B)(6), WHO IS ASSOCIATED WITH SID (B)(6). THERE WAS NO TEST ORDERED FOR THE ALIQUOT TUBE WITH SID (B)(6). IT WAS CONFIRMED THAT THE AFFECTED SAMPLES DID NOT LEAVE THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920709 GLP ALIQUOT MODULE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT AUTOMATION SOLUTIONS GMBH 00380740186821

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALIQUOTER PRINTER II, G-41622-01, UNKNOWN