BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C (701) MODULE

    MDR report key: 7822538 · Received August 28, 2018

    Report

    Report Number
    1823260-2018-02900
    Event Type
    Malfunction
    Date Received
    August 28, 2018
    Date of Event
    August 9, 2018
    Report Date
    August 28, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630928255
    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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR GLUC3 GLUCOSE HK GEN.3 AND A SECOND PATIENT SAMPLE TESTED FOR ALB2 ALBUMIN GEN.2 ON A COBAS 8000 C (701) MODULE. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. AN ALIQUOT CUP OF THE FIRST SAMPLE INITIALLY RESULTED WITH A GLUC3 VALUE OF 17 MG/DL. THE SAME ALIQUOT CUP WAS REPEATED ON A SECOND C 701 ANALYZER, RESULTING AS 92 MG/DL. A NEW ALIQUOT WAS MADE FROM THE PARENT TUBE AND TESTED ON THE SECOND C 701 ANALYZER, RESULTING AS 92 MG/DL. AN ALIQUOT CUP OF THE SECOND SAMPLE INITIALLY RESULTED WITH AN ALB2 VALUE OF 5.7 G/DL ON (B)(6) 2018. THE SAME ALIQUOT CUP WAS REPEATED ON A SECOND C 701 ANALYZER, RESULTING AS 4.2 G/DL. A NEW ALIQUOT WAS MADE FROM THE PARENT TUBE AND TESTED ON THE SECOND C 701 ANALYZER, RESULTING AS 4.2 G/DL. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE GLUC3 REAGENT LOT NUMBER WAS 30265201, WITH AN EXPIRATION DATE OF 31-MAR-2019. THE ALB2 REAGENT LOT NUMBER WAS 33647301, WITH AN EXPIRATION DATE OF 31-JUL-2019. THE CUSTOMER INSPECTED THE C 701 ANALYZER AND SUSPECTED THAT THERE WAS AN ISSUE WITH THE CELL RINSE UNIT. THE FIELD SERVICE ENGINEER DETERMINED THAT THERE WAS A DRIP IN THE DETERGENT DISPENSE AND ADJUSTED THE INCOMING PRESSURE. HE RAN PRECISION STUDIES AND ALL CHECKS PASSED. BASED ON A REVIEW OF WORLDWIDE DATA OF QC RECOVERY FOR THE REAGENT/CALIBRATOR LOT COMBINATION USED BY THE CUSTOMER, NO REAGENT ISSUE WAS FOUND. INVESTIGATIONS HAVE DETERMINED THAT THE ISSUE WAS RESOLVED BY THE SERVICE ACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663835 COBAS 8000 C (701) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C701 NA 04015630928255

    Patients

    Seq Age Sex Outcome Treatment
    1