BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 7203216 · Received January 18, 2018

    Report

    Report Number
    1823260-2018-00169
    Event Type
    Malfunction
    Date Received
    January 18, 2018
    Date of Event
    January 4, 2018
    Report Date
    February 14, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPONENT CODE - DEVICE SUBASSEMBLY = GEAR PUMP HEAD.

    Additional Manufacturer Narrative · 1

    NO FURTHER ISSUES OCCURRED AFTER THE SERVICE ACTIONS WERE COMPLETED. INVESTIGATIONS DETERMINED THE ISSUE TO BE CAUSED BY INCOMPLETE MAINTENANCE OF THE GEAR PUMP HEAD.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR TWO PATIENT SAMPLES TESTED FOR PHOS2 PHOSPHATE (INORGANIC) VER.2 (PHOS) ON A COBAS 8000 C 702 MODULE (C702). THE ERRONEOUS INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE PHYSICIAN REQUESTED A REPEAT OF THE SAMPLES AND THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE SAMPLES WERE INITIALLY PROCESSED ON A MODULAR PRE-ANALYTICS SYSTEM AND TESTED EITHER ON (B)(6) 2017. THE CUSTOMER ALSO NOTED THAT THEY HAD QUALITY CONTROL ISSUES ON THE NIGHT OF (B)(6) 2017 AND THE MORNING OF (B)(6) 2017. CONTROLS WERE FINE WITH ALL OTHER ASSAYS. THE CUSTOMER HAD TO RE-CALIBRATE SEVERAL TIMES DUE TO CALIBRATION ERRORS. PHOS WAS RUNNING ON ANOTHER ANALYZER AT THE SITE AND WAS NOT HAVING THE SAME ISSUE WITH CONTROLS. THE FIRST SAMPLE INITIALLY RESULTED AS 8.1 MG/DL AND REPEATED AS 3.7 MG/DL. THE SECOND SAMPLE, FROM A (B)(6) YEAR OLD FEMALE PATIENT BORN ON (B)(6), INITIALLY RESULTED AS 7.6 MG/DL AND REPEATED AS 2.6 MG/DL. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE PHOS REAGENT LOT NUMBER WAS 250418, WITH AN EXPIRATION DATE OF 31-AUG-2018. THE FIELD SERVICE ENGINEER REPLACED THE REAGENT PROBES. HE ALSO REPLACED THE GEAR PUMP HEAD AND PRESSURE GAUGE AS A PRECAUTION. THE CUSTOMER RAN CALIBRATION AND CONTROLS; THESE PASSED. A FOLLOW UP CALL WAS PLACED WITH THE CUSTOMER THREE DAYS LATER AND CONTROLS WERE WITHIN RANGE. THE UNIT WAS OPERATIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47977 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR