BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 7439213 · Received April 18, 2018

    Report

    Report Number
    1823260-2018-01199
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Date of Event
    April 2, 2018
    Report Date
    April 26, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE. THE PROVIDED CALIBRATION AND QC DATA CONFIRMED THE ASSAY WORKED WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE LOW ELECSYS PTH IMMUNOASSAY RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 4.05 PMOL/L AND THE REPEAT RESULT WAS 24.27 PMOL/L. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 220377. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. NO OTHER ASSAYS WERE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283254 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR