BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    902 HITACHI

    MDR report key: 1712620 · Received June 8, 2010

    Report

    Report Number
    1823260-2010-03377
    Event Type
    Malfunction
    Date Received
    June 8, 2010
    Date of Event
    June 1, 2010
    Report Date
    August 19, 2010
    Manufacturer
    ROCHE DIAGNOSTICS CORPORATION
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON INFORMATION PROVIDED, A SIPPER NOZZLE RELATED ISSUE, SUCH AS CLOT FORMATION IN SIPPER NOZZLE OR A MISADJUSTED SIPPER NOZZLE, MIGHT HAVE CAUSED THE ISSUE. THE SIPPER NOZZLE WAS REPLACED BY THE FIELD SERVICE REPRESENTATIVE. CALIBRATION, QUALITY CONTROL AND PATIENT SAMPLE RESULTS WERE THEN ACCEPTABLE. FOLLOW UP CONFIRMED THE USER HAD NO FURTHER EVENTS SINCE THE SERVICE VISIT. NO ADVERSE EVENTS IN RELATION TO THE ERRONEOUS RESULTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE REVIEW OF WADIANA LOGS RECEIVED FROM THE CUSTOMER AS PART OF TC10-186 PRODUCT NOTIFICATION REVIEW OF PREVIOUSLY REPORTED RESULTS ON THE ORTHO PROVUE ANALYZER, THE FOLLOWING INCIDENT WAS IDENTIFIED. THIS INCIDENT WAS RELATED TO FAILURE TO DISPENSE PLASMA FOLLOWING A CANCELLED MICROTUBE PER TC 10-174 CANCELLED MICROTUBES USING SOFTWARE VERSION 3.1 ON THE ORTHO PROVUE ANALYZER. THE EVENT WAS RELATED TO THE CROSSMATCH-IS TEST. EVENT OCCURRED ON (B)(6) 2010 AT 13:13 TO BATCH 8430. PROVUE FAILED TO DELIVER PATIENT PLASMA INTO THE MICROWELL # 3 TO THE MTS BUFFERED GEL CARD (BARCODE # 09210904022406014203) FOR THE IS CROSSMATCH TO SAMPLE ID (B)(4) (POSITION #16 ON THE CAROUSEL) TO DONOR ID# (B)(6). PROVUE HAD RESULTED THE TEST WITH A NEGATIVE RESULT.

    Description of Event or Problem · 1

    THE USER NOTED AN ISSUE WITH HIGH ISE RESULTS. SPECIFIC NUMBER OF PATIENT SAMPLES IMPACTED WAS NOT PROVIDED. RESULTS FOR CTONROLS AND APPROXIMATELY 3 PATIENT SAMPLES WERE PROVIDED. OF THE DATA PROVIDED, THE RESULTS FOR ONE PATIENT SAMPLE AND THE CONTROL MATERIAL WERE DISCREPANT. NO UNIT OF MEASURE WAS PROVIDED. SAMPLE SODIUM RESULTS WERE 117.3 WITH A DATA FLAG AND 150.3, POTASSIUM RESULTS WERE 5.84 WITH A DATA FLAG AND 4.59. CONTROL SODIUM RESULTS WERE 121.3, 138.4, 120.5 AND 121.5. NO INFORMATION WAS PROVIDED TO DETERMINE IF ERRONEOUS RESULTS WERE REPORTED OR IF PATIENTS WERE ADVERSELY AFFECTED. THE LOT NUMBERS OF THE SODIUM AND POTASSIUM ELECTRODES WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 902 HITACHI CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1