BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 7523550 · Received May 17, 2018

    Report

    Report Number
    1823260-2018-01537
    Event Type
    Malfunction
    Date Received
    May 17, 2018
    Date of Event
    May 3, 2018
    Report Date
    June 20, 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

    CALIBRATION SIGNALS FOR THE CALIBRATION PERFORMED ON (B)(6) 20187 WERE OK. QUALITY CONTROLS WERE WITHIN ACCEPTABLE RANGE ON (B)(6) 2018. NO REAGENT ISSUES ARE EVIDENT BASED ON CALIBRATION AND CONTROL DATA. UPON REVIEW OF THE ALARM TRACE, NO ISSUES WERE SEEN. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR THE ELECSYS TESTOSTERONE II ASSAY (TESTO) ON A COBAS 6000 E 601 MODULE (E601). THE SAMPLE INITIALLY RESULTED AS 172.6 NG/DL AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN ASKED FOR A REPEAT OF THE SAMPLE AS THE VALUE WAS WITHIN THE NORMAL REFERENCE RANGE FOR TESTO AND DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENT. THE SAMPLE WAS REPEATED, RESULTING AS < 2.5 NG/DL, WHICH WAS REPORTED OUTSIDE OF THE LABORATORY AS < 12 NG/DL. THE SAMPLE WAS ALSO REPEATED ON A DIFFERENT ANALYZER, RESULTING AS < 12 NG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TESTO REAGENT LOT NUMBER WAS 232994. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER COULD NOT DETERMINE A CAUSE. THE CUSTOMER RAN PRECISION STUDIES. THE CUSTOMER NOTED THAT THE FIELD SERVICE ENGINEER HAS BEEN ON SITE PREVIOUSLY FOR ISSUES WITH THE MEASURING CELL AND HAS CHANGED A BOARD ON THE ANALYZER MORE THAN ONCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364456 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR ACETAMINOPHEN| CYANOCOBALAMINE INJECTION| DIPHENHYDRAMINE| DOCUSATE SODIUM| IRON SUCROSE| MAGNESIUM SULFATE| MORPHINE| ONDANSETRON| SALINE| SEFAZOLIN