BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIKACIN

    MDR report key: 16994469 · Received May 24, 2023

    Report

    Report Number
    1823260-2023-01734
    Event Type
    Malfunction
    Date Received
    May 24, 2023
    Date of Event
    May 9, 2023
    Report Date
    July 17, 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
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT FIND A PRODUCT ISSUE. THE MANUAL DILUTION FACTOR HAS TO BE APPLIED MANUALLY.

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELDS A2 AND A3 HAVE BEEN UPDATED. IT WAS CONFIRMED THAT THE VALUE OF 29.8 G/ML IS THE RESULT OF A MANUAL DILUTION 1:1. PER PRODUCT LABELING: "MANUALLY DILUTE SAMPLES ABOVE THE MEASURING RANGE 1 + 1 WITH THE PRECISET TDM II DILUENT (0 G/ML) AND REASSAY. MULTIPLY THE RESULT BY 2 TO OBTAIN THE SPECIMEN VALUE." THE CORRECT VALUE IS THEREFORE 59.6 G/ML.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE AMIK GEN.2 (AMIKACIN) RESULT FROM COBAS PRO C 503 ANALYTICAL UNIT SERIAL NUMBER (B)(6). THE INITIAL RESULT WAS 69.8 G/ML WITH A DATA FLAG. THE REPEAT RESULT WITH AN ANALYZER DILUTION WAS 71.4 G/ML WITH A DATA FLAG. THE CUSTOMER PERFORMED A MANUAL 1:2 DILUTION AND THE RESULT WAS 29.8 G/ML. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897043 AMIKACIN AMIKACIN SERUM ASSAY KLP ROCHE DIAGNOSTICS NA 1234 07613336133514

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female