BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HITACHI 902 ANALYZER

    MDR report key: 3103126 · Received May 9, 2013

    Report

    Report Number
    1823260-2013-02859
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 23, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K921661
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE QUALITY CONTROL DATA AT THE TIME OF THE EVENT WAS ACCEPTABLE. PATIENT SAMPLE IS NOT AVAILABLE FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE CREATININE JAFFÉ (CREJ) RESULTS FOR ONE PATIENT ON THEIR 902 ANALYZER. THE PATIENT'S INITIAL CREJ RESULT WAS 2.95 MG/DL ACCOMPANIED BY A DATA FLAG AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED IN ANOTHER LABORATORY ON AN UNKNOWN METHOD, AND THE RESULT WAS 0.9 MG/DL. ON (B)(6) 2013, A SECOND SAMPLE DRAWN AT THE SAME TIME AS THE ORIGINAL SAMPLE WAS TESTED AND THE RESULT WAS 0.99 MG/DL. ON (B)(6) 2013, THE PATIENT'S FIRST SAMPLE WAS REPEATED THREE TIMES AND THE RESULTS WERE 5.05 MG/DL ACCOMPANIED BY A DATA FLAG, 4.81 MG/DL ACCOMPANIED BY A DATA FLAG, AND 11.11 MG/DL ACCOMPANIED BY A DATA FLAG. AS THE RESULT FROM THE SECOND SAMPLE MATCHED THE RESULT FROM THE OTHER LABORATORY, AND 0.99 MG/DL WAS ISSUED AS A CORRECTED REPORT. THERE WERE NO REPORTS OF ANY ADVERSE EVENT. THE CREJ REAGENT LOT NUMBER WAS 663128 AND THE EXPIRATION DATE WAS 08/30/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203018 HITACHI 902 ANALYZER CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1