BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 18496609 · Received January 11, 2024

    Report

    Report Number
    3016438761-2024-00018
    Event Type
    Malfunction
    Date Received
    January 11, 2024
    Date of Event
    December 31, 2023
    Report Date
    January 25, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137366
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ALINITY I PROCESSING MODULE SERIAL # (B)(6) WAS INSPECTED, AND THE FIELD SERVICE ENGINEER (FSE) OBSERVED CRYSTALS AT THE R1 AND R2 PUMPS. THE FSE DETERMINED THAT THE 100UL BUFFER PUMP (ROHS) REQUIRED CLEANING AND TIGHTENED THE CONNECTIONS FOR THE WZ1 AND WZ2 WASH ZONE MANIFOLD, NO VALVES. THE ALINITY I PROCESSING MODULE FUNCTION WAS THEN VERIFIED WITH A CONTROL RUN. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL ISSUES RELATED TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY A TREND FOR THE 100UL BUFFER PUMP (ROHS), WZ1 AND WZ2 WASH ZONE MANIFOLD, NO VALVES OR ALINITY I AS WITH REGARDS TO THE CUSTOMER REPORTED EVENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES RELATED TO THE 100UL BUFFER PUMP (ROHS) OR WZ1 AND WZ2 WASH ZONE MANIFOLD, NO VALVES AND CUSTOMER REPORTED EVENT. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED ISSUE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. 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 FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I GENERATED FROM AN ALINITY I PROCESSING MODULE. THE CUSTOMER PROVIDED THE FOLLOWING INFORMATION: CUSTOMER REFERENCE RANGE: 0-34.2 PG/ML THE INITIAL RESULT WAS 256.8 PG/ML, THE REPEAT RESULT WAS 0 PG/ML. IT WAS REPORTED THAT PARTS OF THE INSTRUMENT WERE CLEANED AND WHEN THE SAMPLE WAS REPEATED, THE RESULT WAS 0 PG/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I GENERATED FROM AN ALINITY I PROCESSING MODULE. THE CUSTOMER PROVIDED THE FOLLOWING INFORMATION: CUSTOMER REFERENCE RANGE: 0-34.2 PG/ML THE INITIAL RESULT WAS 256.8 PG/ML, THE REPEAT RESULT WAS 0 PG/ML. IT WAS REPORTED THAT PARTS OF THE INSTRUMENT WERE CLEANED AND WHEN THE SAMPLE WAS REPEATED, THE RESULT WAS 0 PG/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828176 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALIN I HS TROP 200T CN, 08P13-74, (B)(6) | ALIN I HS TROP 200T CN, 08P13-74, (B)(6)