BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2517506-2017-00411

    MDR report key: 6506946 · Received April 20, 2017

    Report

    Report Number
    2517506-2017-00411
    Event Type
    Malfunction
    Date Received
    April 20, 2017
    Date of Event
    March 23, 2017
    Report Date
    March 26, 2018
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE CCC SPECIALIST AND STATED THAT THEY INADVERTENTLY TESTED AN INFANT PATIENT SAMPLE WITHOUT A SMALL SAMPLE CONTAINER. QUALITY CONTROLS ON THE DAY OF THE EVENT WERE WITHIN ACCEPTABLE RANGE. THE SAMPLE FROM THE PATIENT WAS COLLECTED IN A TUBE. HOWEVER, THE OPERATOR SHOULD HAVE PUT A SAMPLE CUP CONTAINER WITH THE WHOLE BLOOD SAMPLE ON TOP OF THE SPECIMEN COLLECTION TUBE FOR TACROLIMUS PROCESSING. THE ISSUE WAS RESOLVED BY REPEATING TRACROLIMUS TESTING FOR THE SAMPLE BY PLACING THE SAMPLE CONTAINER CUP ON TOP OF THE TUBE. THE CAUSE OF THE DISCORDANT, FALSELY LOW TACROLIMUS RESULTS WAS DUE TO THE SAMPLE NOT BEING PROCESSED WITH THE SAMPLE CUP CONTAINER. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2517506-2017-00411 WAS FILED ON 20-APR-2017. CORRECTED INFORMATION (21-MAR-2018): SECTION HAS BEEN UPDATED WITH THE CORRECT LEGAL MANUFACTURING ADDRESS.

    Description of Event or Problem · 1

    THE CUSTOMER OF A DIMENSION XPAND PLUS WITH HM INSTRUMENT CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND STATED THAT THEY INADVERTENTLY TESTED AN INFANT PATIENT SAMPLE WITHOUT A SMALL SAMPLE CONTAINER (SSC). AS A RESULT, DISCORDANT, FALSELY LOW TACROLIMUS RESULTS WERE OBTAINED UPON INITIAL AND REPEAT TESTING. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE PHYSICIAN INCREASED THE DOSAGE OF TACROLIMUS DUE TO THE FALSELY LOW RESULTS. THE CUSTOMER REPEATED THE SAMPLE TWICE WITH THE SMALL SAMPLE CONTAINER ON THE SAME INSTRUMENT, RESULTING HIGHER BOTH TIMES. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY LOW TACROLIMUS RESULTS.

    Patients

    Seq Age Sex Outcome Treatment
    1