BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 3271878 · Received August 8, 2013

    Report

    Report Number
    1823260-2013-04769
    Event Type
    Malfunction
    Date Received
    August 8, 2013
    Date of Event
    April 30, 2013
    Report Date
    August 8, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 FALSE POSITIVE BENZODIAZEPINE AND AMPHETAMINE RESULTS THAT WERE CONFIRMED TO BE NEGATIVE BY GS/MS FOR OVER A YEAR. THE CUSTOMER STATED THEY RUN 25-45 SAMPLES PER DAY AND RECEIVE FALSE POSITIVE BENZODIAZEPINE RESULTS FOR APPROXIMATELY 2-3 URINE SAMPLES PER DAY. ONLY THE FALSE POSITIVE BENZODIAZEPINE RESULTS WERE A REPORTABLE MALFUNCTION. DATA WAS PROVIDED FOR 16 PATIENT SAMPLES THAT WERE TESTED BETWEEN (B)(6) 2013. THE PRESUMPTIVE POSITIVE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE GC/MS RESULTS WERE BELIEVED TO CORRECT. NO PATIENTS WERE ADVERSELY AFFECTED. THE BENZODIAZEPINE REAGENT LOT NUMBERS WERE 66823001 WITH AN EXPIRATION DATE OF 01/31/2014 AND 68071701 WITH AN EXPIRATION DATE OF 08/31/2014. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE AND NOTED THERE WAS A NEW LOT NUMBER OF QC MATERIAL IN USE. TO VERIFY THE ANALYZER OPERATION, HE RAN PRECISION TESTING WHICH PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373152 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1