BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 2971887 · Received February 21, 2013

    Report

    Report Number
    1823260-2013-01105
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ALANINE AMINOTRANSFERASE (ALT) RESULTS FOR TWO PATIENT SAMPLES. PATIENT SAMPLE 1 INITIAL RESULT FROM ANALYTICAL D MODULE ANALYZER SERIAL NUMBER (B)(4) WAS 2712 U/L WITH A DATA FLAG. THE REPEAT RESULT ON ANALYTICAL P MODULE ANALYZER SERIAL NUMBER (B)(4) WAS 8 U/L AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS THEN REPEATED WITH A DILUTION ON ANALYTICAL P MODULE ANALYZER SERIAL NUMBER (B)(4) AND THE RESULT WAS 3200 U/L WITH A DATA FLAG. ON (B)(6) 2013, PATIENT SAMPLE 2 INITIAL RESULT FROM ANALYTICAL D MODULE ANALYZER SERIAL NUMBER (B)(4) WAS 892 U/L WITH A DATA FLAG. THE REPEAT RESULT ON ANALYTICAL P MODULE ANALYZER SERIAL NUMBER (B)(4) WAS 14 U/L AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS THEN REPEATED WITH A DILUTION ON ANALYTICAL P MODULE ANALYZER SERIAL NUMBER (B)(4) AND THE RESULT WAS 921 U/L WITH A DATA FLAG. THE RESULTS WERE CONFIRMED ON ANALYTICAL D MODULE ANALYZER SERIAL NUMBER (B)(4) BEFORE BEING TESTED ON ANALYTICAL P MODULE SERIAL NUMBER (B)(4). NO SPECIFIC RESULTS WERE PROVIDED, BUT THE CUSTOMER STATED THE RESULTS WERE ACCOMPANIED BY DATA FLAGS. THE RESULTS OF 921U/L AND 3200 U/L FROM ANALYTICAL P MODULE SERIAL NUMBER (B)(4) WERE BELIEVED TO BE CORRECT. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE ALT REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE PROBLEM DETERMINED THE DILUTION SALINE WAS CONTAMINATED. HE CHECKED AND VERIFIED SYSTEM PRESSURES, TEMPERATURES AND RINSE HEIGHTS. HE REPLACED THE SALINE REAGENT USED FOR DILUTIONS AND WORKED WITH THE CUSTOMER WHO PERFORMED A 20 CUP PLASMA POOL PRECISION. THE CUSTOMER USED MODULE D1 TO RUN THE INITIAL SAMPLE WITH HIGH LINEARITY, CAUSING THE P MODULE TO RE-REPEAT THE SAMPLE WITH 10:1 DILUTION. ALL TEST RESULTS WERE WITHIN GUIDELINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77071 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1