BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 3872680 · Received June 13, 2014

    Report

    Report Number
    1823260-2014-04335
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 31, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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. BASED ON EVALUATION OF THE PROVIDED CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED.

    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 MAGNESIUM RESULTS FOR NINE PATIENT SAMPLES. THE SAMPLES WERE REPEATED ON THE SAME COBAS INTEGRA 800 ANALYZER AND ANOTHER COBAS INTEGRA 800 ANALYZER. OF THE DATA PROVIDED, ONLY THE RESULTS FOR SEVEN OF THE SAMPLES WERE DISCREPANT. PATIENT SAMPLE 1 INITIAL RESULT WAS 2.4 MG/DL. THE REPEAT RESULT ON THE SAME ANALYZER WAS 1.7 MG/DL AND ON THE OTHER ANALYZER WAS 1.7 MG/DL. PATIENT SAMPLE 2 WAS FROM A FEMALE PATIENT. THE INITIAL RESULT WAS 2.6 MG/DL. THE REPEAT RESULT ON THE SAME ANALYZER WAS 1.9 MG/DL AND THE REPEAT RESULT ON THE OTHER ANALYZER WAS 1.8 MG/DL. PATIENT SAMPLE 3 WAS FROM A MALE WITH A BIRTHDATE OF (B)(6) 1952. THE INITIAL RESULT WAS 2.8 MG/DL. THE REPEAT RESULT ON THE SAME ANALYZER WAS 3.0 MG/DL AND THE REPEAT RESULT ON THE OTHER ANALYZER WAS 2.2 MG/DL. PATIENT SAMPLE 4 WAS FROM A FEMALE WITH A BIRTHDATE OF (B)(6) 1932. THE INITIAL RESULT WAS 2.7 MG/DL. THE REPEAT RESULT ON THE SAME ANALYZER WAS 2.7 MG/DL AND THE REPEAT RESULT ON THE OTHER ANALYZER WAS 2.0 MG/DL. PATIENT SAMPLE 5 WAS FROM A MALE WITH A BIRTHDATE OF (B)(6) 1940. THE INITIAL RESULT WAS 2.2 MG/DL. THE REPEAT RESULT ON THE SAME ANALYZER WAS 1.4 MG/DL AND THE REPEAT RESULT ON THE OTHER ANALYZER WAS 1.4 MG/DL. PATIENT SAMPLE 6 WAS FROM A FEMALE WITH A BIRTHDATE OF (B)(6) 1961. THE INITIAL RESULT WAS 2.7 MG/DL. THE REPEAT RESULT ON THE SAME ANALYZER WAS 2.0 MG/DL AND THE REPEAT RESULT ON THE OTHER ANALYZER WAS 1.9 MG/DL. PATIENT SAMPLE 7 WAS FROM A MALE WITH A BIRTHDATE OF (B)(6) 1940. THE INITIAL RESULT WAS 2.7 MG/DL. THE REPEAT RESULT ON THE SAME ANALYZER WAS 1.9 MG/DL AND THE REPEAT RESULT ON THE OTHER ANALYZER WAS 2.1 MG/DL. THE REPEAT RESULTS FROM THE OTHER ANALYZER WERE BELIEVED TO BE CORRECT. THE ERRONEOUS RESULT FOR ONE PATIENT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DID NOT HAVE ACCESS TO THE INFORMATION TO DETERMINE WHICH PATIENT THIS WAS. A CORRECTED REPORT WAS ISSUED. THERE WAS NO ADVERSE EVENT. THE MAGNESIUM REAGENT LOT NUMBER WAS 68762901 WITH AN EXPIRATION DATE OF 04/30/2015. THE FIELD SERVICE REPRESENTATIVE FOUND THERE WAS A FAULTY ST1 CABLE AND REPLACED IT. THE CUSTOMER RAN PRECISION TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349013 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 053 YR