BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C513 MODULE

    MDR report key: 7260233 · Received February 9, 2018

    Report

    Report Number
    1823260-2018-00390
    Event Type
    Malfunction
    Date Received
    February 9, 2018
    Date of Event
    January 19, 2018
    Report Date
    March 6, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE WAS RESOLVED BY THE SERVICE ACTIONS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED HIGH RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED FOR A1C-3 TINA-QUANT HEMOGLOBIN A1C GEN.3 (HBA1C) ON A COBAS C 513 (C513) ANALYZER. WHEN THESE SAMPLES WERE REPEATED ON (B)(6) 2018, SOME VALUES CHANGED UP TO 50 %. THE CUSTOMER PROVIDED DATA FOR ONE PATIENT SAMPLE THAT HAD AN ERRONEOUS HBA1C RESULT WHICH WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS 12.3 % AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE DOCTOR. THE DOCTOR DID NOT BELIEVE THE RESULT. THE SAMPLE WAS REPEATED ON (B)(6) 2018, RESULTING AS 6.7 %. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE HBA1C REAGENT LOT NUMBER WAS 211965. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER DETERMINED THAT THE CELL RINSE DETERGENT LEVEL DISPENSE WAS TOO HIGH. THE INSTRUMENT CHECK FAILED. HE ADJUSTED THE CELL RINSE UNIT. HE RAN ANOTHER INSTRUMENT CHECK AND IT WAS WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103864 COBAS C513 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C513 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR