BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MAX CLINICAL

    MDR report key: 10188119 · Received June 24, 2020

    Report

    Report Number
    1119779-2020-00172
    Event Type
    Malfunction
    Date Received
    June 24, 2020
    Date of Event
    June 9, 2020
    Report Date
    December 31, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    OOI
    UDI-DI
    00382904419165
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY THE COMPLAINT OF "DISCREPANT RESULTS" WAS RECEIVED AGAINST THE BD MAX INSTRUMENT CATALOG NUMBER 441916, SERIAL NUMBER (B)(6). DATABASE ANALYSIS REVIEW BY SSSES AND NFS SHOW NO APPARENT INSTRUMENT ISSUE CONTRIBUTING TO DISCREPANT RESULTS. THE COMPLAINT IS NOT CONFIRMED. THE ROOT CAUSE IS UNKNOWN. THE INVESTIGATION CONSISTED OF A REVIEW OF THE SERVICE NOTES PERTAINING TO THIS ISSUE, THE SERVICE AND INSTALLATION HISTORY OF THE INSTRUMENT AND ASSOCIATED COMPLAINT TRENDING DATA. NO PARTS OR MATERIALS WERE RETURNED FOR INVESTIGATION. NO NEW RISKS, OR HAZARDS WERE IDENTIFIED AS A RESULT OF THE COMPLAINT H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE INSTRUMENT MAX CLINICAL A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. A CONFIRMATORY TEST WAS PERFORMED THE NEXT DAY AND THE RESULT WAS NEGATIVE. THE PATIENT WAS ISOLATED WHILE THE RESULT WAS REPEATED.

    Additional Manufacturer Narrative · 1

    MULTIPLE 510K NUMBERS: K111860, K130470. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE INSTRUMENT MAX CLINICAL A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. A CONFIRMATORY TEST WAS PERFORMED THE NEXT DAY AND THE RESULT WAS NEGATIVE. THE PATIENT WAS ISOLATED WHILE THE RESULT WAS REPEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654534 INSTRUMENT MAX CLINICAL MOLECULAR DIAGNOSTICS OOI BECTON, DICKINSON & CO. 441916 00382904419165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other