BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 6225246 · Received January 5, 2017

    Report

    Report Number
    1823260-2017-00020
    Event Type
    Malfunction
    Date Received
    January 5, 2017
    Date of Event
    December 12, 2016
    Report Date
    February 8, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. QC RESULTS AROUND THE TIME OF THE EVENT WERE WITHIN THE ACCEPTABLE RANGE. BASED ON THE INFORMATION PROVIDED AND THE CUSTOMER'S STATEMENT THAT THE SAMPLE WAS OF POOR QUALITY, A PREANALYTICAL ISSUE WAS MOST LIKELY.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE HIGH CREP2 CREATININE PLUS VER.2 RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 175 UMOL/L AND WAS REPORTED TO THE DOCTOR. THE DOCTOR ORDERED A NEW SAMPLE BE DRAWN FROM THE PATIENT ON THE SAME DAY. THE RESULT FROM THE NEW SAMPLE WAS 41UMOL/L WHICH WAS AS EXPECTED. THE ORIGINAL SAMPLE WAS RETRIEVED AND A SIGNIFICANT AMOUNT OF "FIBROUS FLOATIES" WERE SEEN IN THE SAMPLE. THE SAMPLE WAS RECENTRIFUGED AND RESTED. THE REPEAT RESULT WAS 44 UMOL/L. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 160620 WITH AN EXPIRATION DATE OF 03/31/2018. BASED ON THE INFORMATION PROVIDED, A PREANALYTICAL ISSUE WAS A POSSIBLE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9391 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS I800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR