BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3002637618-2018-00019

    MDR report key: 7313468 · Received March 5, 2018

    Report

    Report Number
    3002637618-2018-00019
    Event Type
    Malfunction
    Date Received
    March 5, 2018
    Date of Event
    February 6, 2018
    Report Date
    May 29, 2018
    PMA / PMN Number
    K073537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS INVESTIGATOR STATES THAT MANY FILES HAVE BEEN PROVIDED AND UPLOADED, HOWEVER THEY ARE EITHER FROM A DAY OTHER THAN THE DAY OF THE EVENT OR THE FILE SHOWS AS BEING ONLY 1KB. UNFORTUNATELY THERE IS NOT SUFFICIENT/PERTINENT DATA FOR R&D TO REVIEW TO PROVIDE A ROOT CAUSE OF THIS DISCREPANCY. PROPER SAMPLING AND THOROUGH MIXING IS VERY IMPORTANT FOR ACCURATE THB RESULTS. TO APPROPRIATELY MIX RED BLOOD CELLS, WHOLE BLOOD SPECIMENS NEED TO BE MIXED IN SEVERAL PLANES (ROLLING BACK-AND-FORTH AND CIRCULAR TOP-OVER-BOTTOM AND/OR FIGURE-8 STYLE).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT REPEAT TESTING WAS PERFORMED TO CONFIRM CORRECT RESULTS AND A CORRECTED REPORT WAS ISSUED. SIEMENS HAS REQUESTED THE DATA FILES TO INVESTIGATE THIS EVENT. THE CAUSE FOR THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT TOTAL HEMOGLOBIN RESULTS WHEN RUN ON THREE DIFFERENT RL 1265 ANALYZERS AND ANOTHER SIEMENS LAB ANALYZER. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR