BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 9175320 · Received October 10, 2019

    Report

    Report Number
    3002809144-2019-00602
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Report Date
    November 7, 2019
    Manufacturer
    ABBOTT GERMANY
    Product Code
    JJE
    UDI-DI
    00380740137380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION FROM THE CUSTOMER INDICATED THEY POUR NEONATAL SAMPLES INTO SAMPLE CUPS FOR TESTING. IN SOME INSTANCES THE INSTRUMENT GENERATED INCORRECT RESULTS INSTEAD OF AN ASPIRATION ERROR MESSAGE. SOME OF THESE SPURIOUS LOW RESULTS WERE ATTRIBUTED TO A SUBOPTIMAL FLAGGING ALGORITHM FOR SAMPLE ASPIRATION. A REVIEW OF THE AC01041 SERVICE HISTORY DID NOT REVEAL ADDITIONAL COMPLAINTS WHERE DISCORDANT RESULTS WERE GENERATED INSTEAD OF ASPIRATION ERRORS WHEN CLOTS WERE PRESENT, OR INSUFFICIENT SAMPLE WAS PRESENTED, OR THE SAMPLE PROBE ENTERED THE SAMPLE TUBE SEPARATOR GEL. A 12-MONTH REVIEW OF COMPLAINT AND TRENDING DATA FOR ALINITY C PROCESSING MODULE FOUND NO TRENDS RELATED TO THE COMPLAINT ISSUE. MANUFACTURING DOCUMENTATION FOR THE ANALYZER WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE ISSUE. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY C PROCESSING MODULE WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT IDENTIFIER: MULTIPLE = 190810130001 AND 190721175302.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY DEPRESSED TOTAL BILIRUBIN RESULTS WHILE USING THE ALINITY C ANALYZER. CASE 190810-1300: SAMPLE ID 190810130001 GENERATED 1.8 MG/DL. THE PATIENT'S PREVIOUS RESULT WAS 5.6 MG/DL AND THE SUBSEQUENT SAMPLE WAS 4.5 MG/DL. CASE 190721-1753: SAMPLE ID 190721175302 GENERATED 6.5 MG/DL. THE PATIENT'S PREVIOUS RESULT WAS 9.0 MG/DL AND THE SUBSEQUENT SAMPLE WAS 14.1 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970698 ALINITY C PROCESSING MODULE AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT GERMANY 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 ALINITY C TOTAL BILIRUBIN, LIST 04V51-21,| ALINITY C TOTAL BILIRUBIN, LIST 04V51-21,| LOT UNKNOWN| LOT UNKNOWN