BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 7392408 · Received April 3, 2018

    Report

    Report Number
    1823260-2018-01035
    Event Type
    Malfunction
    Date Received
    April 3, 2018
    Date of Event
    February 24, 2018
    Report Date
    September 5, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE A1C-3 EXPIRATION DATE WAS 31-JAN-2019. BASED ON THE CALIBRATION DATA PROVIDED, CALIBRATION SHIFTS AND FREQUENT CALIBRATION FAILURES WERE OBSERVED. BASED ON THE LIMITED INFORMATION PROVIDED BY THE CUSTOMER, THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    IT WAS DETERMINED THERE IS NO GENERAL PRODUCT ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED HIGH RESULTS FOR 2 PATIENTS TESTED FOR TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION (A1C-3) ON A COBAS 6000 C (501) MODULE. BASED ON THE DATA PROVIDED, THE RESULTS FOR 1 PATIENT WERE ERRONEOUS. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL A1C-3 RESULT WAS 10.7% ON THE C501 MODULE. THE REPEAT RESULT FROM ANOTHER LABORATORY USING AN UNSPECIFIED METHOD WAS 5.4%. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE A1C-3 REAGENT LOT NUMBER WAS 253327. THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236320 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR