BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 601 MODULE

    MDR report key: 17309093 · Received July 12, 2023

    Report

    Report Number
    1823260-2023-02227
    Event Type
    Malfunction
    Date Received
    July 12, 2023
    Date of Event
    June 16, 2023
    Report Date
    July 21, 2023
    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
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER INVESTIGATIONS PERFORMED AT THE CUSTOMER SITE, IT WAS DETERMINED THAT THE CUSTOMER'S WATER FILTERING DEVICE DID NOT HAVE ENOUGH CAPACITY TO SUPPLY A SUFFICIENT AMOUNT OF WATER WITH THE DEDICATED PRESSURE TO THE ANALYZER. THE WATER FILTERING DEVICE WAS REPLACED BY A LARGER ONE. THE LABORATORY IS AT A HIGH ALTITUDE (> 2100 M.) AND THE INSTRUMENT IS SPECIFIED FOR USE BELOW 2000 M. THE INVESTIGATION DETERMINED THE DEVICE WAS OPERATING IN THE LABORATORY OUTSIDE OF SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE COBAS 6000 E601 MODULE IS (B)(6).

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS HCG+BETA ON A COBAS 6000 E601 MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN HCG+B VALUE OF 1.16 MIU/ML ACCOMPANIED BY A DATA FLAG INDICATING CARRYOVER. THE SAMPLE WAS RE-PROCESSED WITH A 1:50 DILUTION AND THIS REPEAT JCG+B VALUE WAS 33.39 MIU/ML. THE SAMPLE WAS THEN REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE 1.51 MIU/ML. THIS VALUE WAS CONSIDERED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616919 COBAS E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 64377007 04015630924714
    748370 COBAS E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 64377007 04015630924714

    Patients

    Seq Age Sex Outcome Treatment
    1 Female