BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1597682 · Received February 10, 2010

    Report

    Report Number
    1823260-2010-00908
    Event Type
    Malfunction
    Date Received
    February 10, 2010
    Date of Event
    January 20, 2010
    Report Date
    February 10, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

    Description of Event or Problem · 1

    USER RECEIVED ERRONEOUS RESULTS "EARLIER IN THE WEEK" FOR 2 TO 3 PATIENT SAMPLES RUN IN MICROCUPS. ONLY ONE PATIENT EXAMPLE WAS PROVIDED WHICH WAS DISCREPANT FOR CREATININE. INITIAL RESULT GAVE 0.5 MG/DL. THE SAMPLE WAS REPEATED ON (B) (6) 2010 GIVING 1.5 MG/DL. A CORRECTED REPORT WAS ISSUED WITH THE REPEAT CREATININE RESULT OF 1.5 MG/DL. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. CREATININE REAGENT LOT NUMBER NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND THE SAMPLE PROBE WAS MISADJUSTED. HE PERFORMED VERTICAL AND HORIZONTAL ADJUSTMENTS ON SAMPLE PROBE. CONTROLS WERE RUN TO VERIFY ANALYZER PERFORMING WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER JFY ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1