BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL D MODULE

    MDR report key: 4088424 · Received September 15, 2014

    Report

    Report Number
    1823260-2014-06998
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 23, 2014
    Report Date
    September 15, 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 RECEIVED QUESTIONABLE TOTAL BILIRUBIN RESULTS FOR SEVERAL PATIENTS THAT WERE QUESTIONED BY A PHYSICIAN WHO REQUESTED THE SAMPLES BE REPEATED. OF THE DATA PROVIDED FOR THREE PATIENT SAMPLES, ONLY THE RESULTS FOR TWO WERE DISCREPANT. PATIENT SAMPLE 1 INITIAL RESULT WAS 0.7 MG/DL AND THE REPEAT RESULT FROM ANOTHER ANALYTICAL D MODULE ANALYZER WAS 13.2 MG/DL. PATIENT SAMPLE 2 WAS FROM A (B)(6) YEAR OLD MALE PATIENT. THE INITIAL RESULT WAS 0.2 MG/DL AND THE REPEAT RESULT FROM ANOTHER ANALYTICAL D MODULE ANALYZER WAS 3.7 MG/DL. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE TOTAL BILIRUBIN R1 REAGENT LOT NUMBER WAS 69199001 WITH AN EXPIRATION DATE OF 02/28/2015. THE TOTAL BILIRUBIN R2 REAGENT LOT NUMBER WAS 68984501 WITH AN EXPIRATION DATE OF 12/31/2014. THE FIELD SERVICE REPRESENTATIVE FOUND A PRECIPITANT BUILDUP IN THE CHANNEL 16 REAGENT LINES WAS PREVENTING THE REAGENT FROM PROPERLY DISPENSING. HE CHANGED BLUE REAGENT NOZZLE TIP AND CLEARED THE CHANNEL 16 REAGENT LINE. HE OBSERVED THE REAGENT DISPENSE IN CORRECT OPERATION DURING A REAGENT PRIME, SUCCESSFULLY RAN CALIBRATION, CONTROLS, AND SEVERAL TESTS ON THE ASSAY. THE ANALYZER SYSTEMS WERE WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568821 ANALYTICAL D MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 024 YR