BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 601 MODULE

    MDR report key: 14876596 · Received June 30, 2022

    Report

    Report Number
    1823260-2022-01922
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    June 7, 2022
    Report Date
    October 12, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924714
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    IN MFR REPORT REF #1823260-2022-01922-00, B5 - DESCRIBE EVENT OR PROBLEM SHOULD HAVE BEEN: "THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS TROPONIN T HS ASSAY RESULT FOR ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 E 601 MODULE. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULT WAS 26 NG/L (POSITIVE). THE FIRST REPEAT RESULT WAS <10 NG/L. THE SECOND REPEAT RESULT AFTER RECENTRIFUGATION WAS <10 NG/L. THE REAGENT LOT NUMBER AND THE EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.". INSTEAD OF: "THE INITIAL REPORTER RECEIVED A QUESTIONABLE TROPONIN RESULT FOR ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 E 601 MODULE. THE SPECIFIC ASSAY WAS REQUESTED BUT NOT PROVIDED. IT IS UNKNOWN IF THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULT WAS 26 NG/L (POSITIVE). THE REPEAT RESULT WAS <10 NG/L. THE REAGENT LOT NUMBER AND THE EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED." ADDITIONAL INVESTIGATION FINDINGS: THE 03-JUN-2022 CALIBRATION SHOWED THAT SIGNAL COUNTS FOR CALIBRATORS 1 AND 2 WERE BELOW THE EXPECTED RANGES. THE THIRD-PARTY QC RESULTS WERE WITHIN THE SPECIFIED RANGES.

    Additional Manufacturer Narrative · 0

    THE LABORATORY MANAGEMENT SOFTWARE SHOWED SAMPLE QUALITY ALARMS. THIS INDICATES AN ISSUE WITH THE WORKFLOW WITHIN THE SAMPLE PREPARATION IN THE PRE-ANALYTIC PHASE. THE INVESTIGATION DETERMINED THAT THE ISSUE WAS CAUSED BY POOR SAMPLE QUALITY.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE TROPONIN RESULT FOR ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 E 601 MODULE. THE SPECIFIC ASSAY WAS REQUESTED BUT NOT PROVIDED. IT IS UNKNOWN IF THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULT WAS 26 NG/L (POSITIVE). THE REPEAT RESULT WAS <10 NG/L. THE REAGENT LOT NUMBER AND THE EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014453 COBAS E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA 04015630924714

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown