BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 3923157 · Received July 9, 2014

    Report

    Report Number
    1823260-2014-05052
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 9, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 ALLEGED THEY RECEIVED QUESTIONABLE CALCIUM RESULTS FOR TWO PATIENTS ON THEIR P-MODULE. BOTH THE DISCREPANT RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULTS AND THE LABORATORY REPEATED THE SAMPLES ON ANOTHER P-MODULE. THE FIRST PATIENT'S INITIAL CALCIUM RESULT WAS 7.6 MG/DL. THE REPEAT RESULT WAS 10.0 MG/DL. THE SECOND PATIENT'S INITIAL CALCIUM RESULT WAS 7.2 MG/DL. THE REPEAT RESULT WAS 9.3 MG/DL. THE REPEAT RESULTS WERE CONSIDERED CORRECT. THE PATIENTS HAD SURGERY DELAYED BY THIS EVENT, BUT THEY WERE NOT ADVERSELY AFFECTED. THE CALCIUM REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND A SEMI-CLOGGED CONCENTRATED WASTE LINE AT THE RINSE STATION 2 CAUSING FLUIDIC FAILURES OF RINSE. HE CLEANED THE NOZZLE TIPS AND THE CONCENTRATED WASTE DRAIN VALVE. A MECHANISM CHECK, CALIBRATION, QUALITY CONTROL, AND A PRECISION CHECK WERE GOOD AND WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401851 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1