BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION

    MDR report key: 10032383 · Received May 7, 2020

    Report

    Report Number
    2517506-2020-00146
    Event Type
    Malfunction
    Date Received
    May 7, 2020
    Date of Event
    April 11, 2020
    Report Date
    June 4, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    UDI-DI
    00842768030024
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 2517506-2020-00146 WAS FILED 07-MAY-2020. CHANGED ASSAY NAME FROM ENZYMATIC CREATININE TO CREATININE. CHANGED ASSAY MNEMONIC FROM EZCR TO CRE2. CORRECTION IN SECTION G1,2. CHANGED MANUFACTURING SITE ADDRESS/PHONE FROM SIEMENS HEALTHCARE DIAGNOSTICS INC 500 GBC DRIVE PO BOX 6101 NEWARK, DE 19714-6101, USA FAX: (B)(4). TO SIEMENS HEALTHCARE DIAGNOSTICS INC.-BROOKFIELD REGISTRATION NUMBER 1226181 101 SILVERMINE ROAD BROOKFIELD, CT 06804, USA. ADDITIONAL INFORMATION (11-MAY-2020): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THEIR INVESTIGATION OF THE DISCORDANT DEPRESSED CREATININE (CRE2) RESULT ON A DIMENSION EXL SYSTEM. HSC HAS REVIEWED THE INFORMATION PROVIDED. QUALITY CONTROL (QC) WAS IN RANGE AND NO ISSUES WERE NOTED WITH OTHER PATIENT SAMPLES INDICATING THAT THE INSTRUMENT AND REAGENTS WERE PERFORMING ACCEPTABLY. REPEAT OF THE SAME SAMPLE YIELDED EXPECTED RESULTS. NO PRODUCT PROBLEM WAS IDENTIFIED. THE CAUSE OF THE EVENT IS UNKNOWN. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION.

    Description of Event or Problem · 0

    A DISCORDANT FALSELY DEPRESSED CREATININE (CRE2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION EXL SYSTEM ON A LATER DATE AND A HIGHER RESULT, CONSIDERED CORRECT, WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CRE2 RESULT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT A DISCORDANT, FALSELY DEPRESSED CREATININE (EZCR) PATIENT RESULT WAS OBTAINED ON A DIMENSION EXL INSTRUMENT. SIEMENS IS INVESTIGATING THE EVENT.

    Description of Event or Problem · 1

    A DISCORDANT FALSELY DEPRESSED ENZYMATIC CREATININE (EZCR) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION EXL SYSTEM ON A LATER DATE AND A HIGHER RESULT, CONSIDERED CORRECT, WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED EZCR RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497077 DIMENSION DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION® EXL¿ WITH LM 00842768030024

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR