BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 3214125 · Received July 9, 2013

    Report

    Report Number
    1823260-2013-04151
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 12, 2013
    Report Date
    September 9, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE PERFORMED THE FOLLOWING ACTIONS: CLEANED THE INCUBATOR BATH, REPLACED OPTICS, REPLACED SQUEEGEES, REPLACED PUMP SUPPORT, REPLACED CUVETTES, ADJUSTED DETERGENT LEVELS, AND CLEANED DETERGENT VALVE.

    Additional Manufacturer Narrative · 1

    THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENTS WERE NOT HARMED BY THE ERRONEOUS RESULTS.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF QUESTIONABLE RESULTS FROM TWO PATIENT SAMPLES TESTED FOR CREATININE JAFFE METHOD (CREA). FOR SAMPLE 1 THE INITIAL CREA WAS 64 UMOL/L; THE REPEAT VALUE WAS 95 UMOL/L. FOR SAMPLE 2 THE INITIAL CREA WAS 86 UMOL/L; THE REPEAT VALUE WAS 105 UMOL/L. THE CUSTOMER WAS ASKED FOR INFORMATION REGARDING WHICH RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND WHETHER ANY ADVERSE EVENTS OCCURRED. THE CUSTOMER DID NOT PROVIDE THE REQUESTED INFORMATION. THE CUSTOMER WAS ALSO ASKED FOR THE LOT NUMBER AND EXPIRATION DATE OF REAGENT INVOLVED. THE CUSTOMER DID NOT PROVIDE THE REQUESTED INFORMATION. A FIELD SERVICE REPRESENTATIVE WENT ONSITE AND FIXED AN ISSUE WITH THE ALIGNMENT OF A SAMPLE PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313029 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1