BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS B 221<6>=ROCHE OMNI S6 SYSTEM

    MDR report key: 3081707 · Received April 29, 2013

    Report

    Report Number
    1823260-2013-02587
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 7, 2013
    Report Date
    February 3, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJC
    PMA / PMN Number
    K945915
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH (MANUFACTURING SITE) WAS UPDATED.

    Additional Manufacturer Narrative · 1

    DATABASES RECEIVED FROM THE CUSTOMER SHOW QUALITY CONTROLS WERE WITHIN RANGE. CALIBRATION VALUES WERE ALSO ACCEPTABLE. COMPARISON MEASUREMENTS WITH A RETENTION SAMPLE OF LOT 25124850 WERE PERFORMED AND WERE WITHIN SPECIFICATION. BATCH RECORDS WERE REVIEWED AND NO ABNORMALITIES WERE FOUND. A QUALITY ISSUE COULD NOT BE VERIFIED WITH MSS-G/L/U SENSOR LOT 21524850. THE CUSTOMER ALSO MEASURES FLUORIDE SAMPLES. DATA PROVIDED SHOWED HIGHER SIGNALS AT THE INTERFERENCE SENSOR WHICH INDICATES USE OF AN UNSUITABLE ANTICOAGULANT. LABELING INDICATES THAT THE ONLY CLOT INHIBITORS THAT MAY BE USED FOR ANALYSES ON THE COBAS B221 SYSTEM ARE HEPARIN SALTS. OTHER CLOT INHIBITORS, SUCH AS FLUORIDE HAVE SIGNIFICANT INFLUENCE ON BLOOD'S PH AND OTHER PARAMETERS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER IS (B)(4) 2013.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR GLUCOSE. THE CAPILLARY SAMPLE INITIALLY RESULTED AS 3.3 MMOL/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. A FLUORIDE SAMPLE FROM THE SAME PATIENT WAS TESTED ON THE LABORATORY CHEMISTRY ANALYZER AND THIS SAMPLE RESULTED WITH A GLUCOSE VALUE OF 1.7 MMOL/L WHICH WAS REPORTED TO THE WARD. THE CUSTOMER WAS NOT SURE OF THE TIMING OF THE FLUORIDE SAMPLE AND HOW CLOSE IT WAS TO THE MEASUREMENT OF THE CAPILLARY SAMPLE. A SAMPLE FROM THE PATIENT WAS ALSO TESTED ON AN INFORM II METER AND THIS RESULTED AS 1.9 MMOL/L. IT IS UNKNOWN IF THE SAMPLE TESTED ON THE INFORM II METER IS THE SAME CAPILLARY SAMPLE THAT WAS INITIALLY TESTED OR IF IT WAS A DIFFERENT SAMPLE. TREATMENT FOR HYPOGLYCEMIA WAS DELAYED FOR THE PATIENT AS A RESULT OF THE ISSUE. THE PATIENT RECEIVED TREATMENT AFTER THE LABORATORY RESULT OF 1.7 MMOL/L WAS RECEIVED BY THE WARD. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE LOT NUMBER OF THE GLUCOSE/LACTATE CASSETTE WAS 21524850. THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183708 COBAS B 221<6>=ROCHE OMNI S6 SYSTEM BLOOD GAS ANALYZER JJC ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 031 MO