BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 11796171 · Received May 10, 2021

    Report

    Report Number
    3002809144-2021-00302
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    January 22, 2021
    Report Date
    June 22, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    JJE
    UDI-DI
    00380740137366
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INCORRECT COMPONENT CODE G01003 WAS INITIALLY SELECTED IN 3002809144-2021-00302-00 AND SUBSEQUENTLY 3002809144-2021-00302-01. THE CORRECT COMPONENT CODE IS G03001

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP IS SUBMITTED TO POPULATE FIELDS D8 AND/OR H6 WITH DATA THAT HAD PREVIOUSLY BEEN PROVIDED IN FIELD H10. THERE IS NO CHANGE TO THE CONTENT OF THE DATA.

    Additional Manufacturer Narrative · 1

    (B)(4). WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. MULTIPLE PATIENTS WERE INVOLVED IN THIS INCIDENT; SID (B)(4). THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED TROUBLESHOOTING AND REPLACED THE ALINITY PIPETTOR PROBES (LIST NUMBER 03R96-01) WHICH WERE CAUSING CARRYOVER. A REVIEW OF SERVICE HISTORY FOR THE ALINITY I, SERIAL NUMBER (B)(4) REVEALED NO ADDITIONAL DISCREPANT B12 RESULTS, NOR DID IT IDENTIFY ANY CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY PIPETTOR PROBES (LIST NUMBER 03R96-01) DID NOT IDENTIFY ANY TRENDS. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I DID NOT IDENTIFY ANY TRENDS. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY PIPETTOR PROBES (LIST NUMBER 03R96-01) OR THE ALINITY I, SERIAL NUMBER (B)(4) WAS IDENTIFIED. THIS EVENT WAS PREVIOUSLY REPORTED VIA 3005094123-2021-00030-00 ON 2/26/21, HOWEVER AN ADDITIONAL PRODUCT WAS IDENTIFIED AS BEING INVOLVED IN THE EVENT AND THEREFORE THIS REPORT IS BEING SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER GENERATED FALSELY ELEVATED ALINITY I B12 RESULTS FOR THREE PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED: SID (B)(6) , TESTED 2X WITH ERROR "UNABLE TO CALCULATE RESULT. FINAL RLU READ IS OUTSIDE THE SPECIFICATION OF THE HIGHEST CALIBRATOR." , REPEATED 6X > 1,476 PMOL/L, REPEATED WITH DILUTION > 4,427 PMOL/L. REPEATED AT OUTSIDE LAB USING ANOTHER PLATFORM (ROCHE); RESULT WAS NOTED AS BEING VERY HIGH ON THIS SAMPLE WITH NO SPECIFIC RESULTS PROVIDED TO ABBOTT. SID (B)(6) , INITIAL RESULT 859 PMOL/L, REPEATED 531 PMOL/L SID (B)(6) ,INITIAL RESULT 520 PMOL/L, REPEATED 520 PMOL/L, 91 PMOL/L, > 1,476 PMOL/L, 72 PMOL/L, 94 PMOL/L, AND > 1,476 PMOL/L. IT WAS NOTED THAT SID (B)(6) , WAS BEING TREATED WITH B12 FOR POISONING AND THE CUSTOMER BELIEVES THE HIGH RESULTS FOR THIS PATIENT CAUSED CARRYOVER FOR SID (B)(6) , LEADING TO THE DISCREPANCY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693255 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT GMBH 03R6501 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1 ALNTY I B12 RGT 1200T K, 07P67-32, 18390UI00| ALNTY I B12 RGT 1200T K, 07P67-32, 18390UI00| ALNTY I B12 RGT 1200T K, 07P67-32, 18390UI00