BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIKACIN

    MDR report key: 16712200 · Received April 11, 2023

    Report

    Report Number
    1823260-2023-01134
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    March 7, 2023
    Report Date
    June 23, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KLP
    UDI-DI
    07613336133514
    PMA / PMN Number
    K032279
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT THE SAMPLE RESULTS ARE NOT DIRECTLY COMPARABLE AS THEY COME FROM DIFFERENT BLOOD COLLECTIONS BUT NOTED THAT THE CONCENTRATION SHOULD DECREASE SINCE THERE WAS NO MEDICATION GIVEN INBETWEEN TESTS. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : NA.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE AMIKACIN RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS PURE C 303 ANALYTICAL UNIT WITH SERIAL NUMBER (B)(4). THE REPORTER COMPLAINED THAT THE RESULTS BETWEEN THE COBAS PURE AND THE COBAS INTEGRA WERE DIFFERENT. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. PATIENT 1 ON (B)(6) 2023, THE INITIAL RESULT FROM THE COBAS INTEGRA WAS 2.3 UG/ML. ON (B)(6) 2023, THE REPEAT RESULT FROM THE COBAS PURE WAS 5.2 UG/ML. PATIENT 2 ON (B)(6) 2023, THE INITIAL RESULT FROM THE COBAS INTEGRA WAS 2.0 UG/ML. ON (B)(6) 2023, THE REPEAT RESULT FROM THE COBAS PURE WAS 5.0 UG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399636 AMIKACIN AMIKACIN SERUM ASSAY KLP ROCHE DIAGNOSTICS NA 631861 07613336133514

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown