BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT VANCOMYCIN ASSAY

    MDR report key: 7124396 · Received December 18, 2017

    Report

    Report Number
    3010939897-2017-00003
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Date of Event
    November 14, 2017
    Report Date
    December 14, 2017
    Manufacturer
    MICROGENICS CORPORATION
    Product Code
    LEH
    UDI-DI
    00380740009847
    PMA / PMN Number
    K050419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED A DISCREPANT VANCOMYCIN PATIENT RESULT OF <1.1 ON A PATIENT WHO WAS RECEIVING VANCOMYCIN. IT WAS RETESTED ON OTHER ARCHITECT IN THE LAB AND THE RESULT WAS REPEATABLE, SAMPLE REPEATED IN 1:4 DILUTION AND READ 14.4. SAMPLE WAS ALIQUOTED AND SENT TO A REFERENCE LAB AND WAS TESTED BY THE SIEMENS VANCO ASSAY AND GOT A RESULT OF 32.0 NG/ML. THE PROBLEM STARTED ON (B)(6) 2017, CUSTOMER HAD 4 RANDOM DRAWS AND 2 DRAWS WERE DONE AFTER MEDICATION WAS GIVEN BETWEEN THE DATES (B)(6). THE SAME PATIENT DRAW FROM (B)(6) 2017 THE PATIENT RESULT WAS 16.4. NO ISSUES WITH OTHER ASSAYS QC ALL IN RANGE AND THE RETEST OF THE PROFICIENCY SAMPLE PRODUCED REPEATABLE RESULTS FROM THE ORIGINAL TESTING. CUSTOMER CONCLUDED THAT THE SAMPLE IS THE CAUSE OF THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905351 ABBOTT VANCOMYCIN ASSAY VANCOMYCIN TEST SYSTEM LEH MICROGENICS CORPORATION 6E44-21 39468FD01 00380740009847

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other