BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 3111682 · Received May 14, 2013

    Report

    Report Number
    1823260-2013-02924
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 QUESTIONABLE RESULTS FOR TINA-QUANT HEMOGLOBIN A1C GEN.2 (HBA1C) ON 29 PATIENTS. OF THOSE 29 PATIENTS, 27 HAD ERRONEOUS RESULTS THAT WERE REPORTED OUTSIDE OF THE LABORATORY. ALL RESULTS ARE IN %. THE CUSTOMER INDICATED THAT THE ERRONEOUS RESULTS WERE GENERATED DURING A RUN OF SAMPLES THAT WERE ACCOMPANIED BY DATA FLAGS. THE CUSTOMER PERFORMED A SAMPLE FLOW CHECK AND FOUND THE ST2 SAMPLE FLOW RATE WAS EXTREMELY LOW. THEY REPLACED THE PROBE AND RESOLVED THE ISSUE. PATIENT 1 HAD TWO SAMPLES COLLECTED AT THE SAME TIME ON (B)(6) 2013. SAMPLE A HAD AN INITIAL RESULT OF 8.34, WHICH WAS REPORTED OUTSIDE OF THE LABORATORY. SAMPLE B HAD AN INITIAL RESULT OF 0.0, ACCOMPANIED BY A DATA FLAG. THIS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. SAMPLE B WAS REPEATED ON THE SAME ANALYZER AND GENERATED A RESULT OF 6.28, WHICH WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN'S OFFICE QUESTIONED THE RESULTS ON THE TWO SAMPLES. SAMPLES A AND B WERE REPEATED ON (B)(6) 2013 ON THE SAME ANALYZER AND GENERATED THE FOLLOWING RESULTS: SAMPLE A: 6.33 AND SAMPLE B: 6.30. THE REPEAT RESULTS WERE DEEMED TO BE THE CORRECT RESULTS, AND A CORRECTED REPORT WAS ISSUED FOR SAMPLE A. THERE WAS NO ADVERSE EVENT. THE INITIAL RESULTS WERE GENERATED ON (B)(6) 2013. THE INITIAL RESULTS FOR ALL THE PATIENTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE REPEATED ON (B)(6) 2013 ON THE SAME ANALYZER. THE REPEAT RESULTS WERE DEEMED TO BE THE CORRECT RESULTS BY THE CUSTOMER, AND CORRECTED REPORTS WERE ISSUED. THERE WAS NO ADVERSE EVENT FOR ANY OF THE PATIENTS. THE LOT OF HBA1C REAGENT IN USE WAS 65778101, WITH AN EXPIRATION DATE OF 11/30/2013. THE FIELD SERVICE REPRESENTATIVE FOUND THAT THERE WAS A PROBLEM WITH THE RT2R PROBE. HE REPLACED THE PROBE HOLDER AND ALL THE REAGENT PROBES. HE PERFORMED A SYSTEM PRIME AND Z CALIBRATION. HE ALSO PERFORMED A CHECK TEST, WHICH PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211982 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1