BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1699985 · Received May 26, 2010

    Report

    Report Number
    2517506-2010-00056
    Event Type
    Injury
    Date Received
    May 26, 2010
    Date of Event
    April 26, 2010
    Report Date
    April 26, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC
    Product Code
    MLM
    PMA / PMN Number
    K060502
    Removal / Correction Number
    Z-2407-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOW RECOVERY OF TACROLIMUS IS DUE TO A NEGATIVE BIAS WITH THIS LOT OF REAGENT. THE DIMENSION TACR INSTRUCTIONS FOR USE STATES "CONFIRMATION OF UNEXPECTED OR ATYPICAL RESULTS BY AN ALTERNATIVE METHODOLOGY IS RECOMMENDED PRIOR TO ANY ADJUSTMENTS IN TACROLIMUS DOSAGE." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE LOW RECOVERY OF TACROLIMUS IS DUE TO A NEGATIVE BIAS WITH THIS LOT OF REAGENT. THE DIMENSION TACR INSTRUCTIONS FOR USE STATES "CONFIRMATION OF UNEXPECTED OR ATYPICAL RESULTS BY AN ALTERNATIVE METHODOLOGY IS RECOMMENDED PRIOR TO ANY ADJUSTMENTS IN TACROLIMUS DOSAGE." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A LOW RECOVERY FOR TACROLIMUS OCCURRED WITH A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN ADJUSTED THE DOSAGE OF TACROLIMUS BASED ON THIS RESULT. THERE WAS NO REPORT OF ANY ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE LOW RECOVERY OF TACROLIMUS.

    Description of Event or Problem · 1

    A LOW RECOVERY FOR TACROLIMUS OCCURRED WITH A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN ADJUSTED THE DOSAGE OF TACROLIMUS BASED ON THIS RESULT. THERE WAS NO REPORT OF ANY ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE LOW RECOVERY OF TACROLIMUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE MLM SIEMENS HEALTHCARE DIAGNOSTICS, INC CA0320

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly| O