BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 IMMUNOASSAY ANALYZER

    MDR report key: 6175873 · Received December 15, 2016

    Report

    Report Number
    1823260-2016-01965
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    December 3, 2016
    Report Date
    December 14, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY HAD BEEN HAVING ISSUES WITH THE QC FOR THE ELECSYS CK-MB STAT IMMUNOASSAY AND ELECSYS PROBNP II IMMUNOASSAY. THE CUSTOMER RECALIBRATED BOTH ASSAYS USING NEW CALIBRATORS AND THE QC PASSED. THE CUSTOMER HAD TWO PATIENTS WITH QUESTIONABLE RESULTS THAT WERE REPEATED AFTER THE RECALIBRATION. PATIENT 1: CKMB INITIAL RESULT WAS < 1 NG/ML WITH A DATA FLAG, REPEAT RESULT WAS 30 NG/ML. PATIENT 2: PBNP INITIAL RESULT WAS <5 PG/ML WITH A DATA FLAG, REPEAT RESULT WAS 7000 PG/ML. THIS PATIENT WAS A (B)(6) MALE. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE CUSTOMER WAS NOT AWARE OF ANY ADVERSE EVENT. THE CK-MB REAGENT LOT NUMBER WAS 118433. THE PBNP REAGENT LOT NUMBER WAS 141292. THE EXPIRATION DATES WERE REQUESTED BUT WERE NOT PROVIDED. THE CUSTOMER RERAN THE QC LATER IN THE DAY AND IT WAS OUT OF RANGE FOR PBNP, BUT THE CKMB WAS STILL WITHIN RANGE. THE CUSTOMER RECALIBRATED THE PBNP ASSAY AGAIN AND THE QC RESULT WAS STILL HIGH. THE FIELD SERVICE REPRESENTATIVE FOUND THE BEAD MIXER SPEED WAS MISADJUSTED. HE ADJUSTED THE BEAD MIXER SPEED TO SPECIFICATION AND RAN SUCCESSFUL PERFORMANCE TESTING. ALL RESULTS WERE WITHIN SPECIFICATION. THE CUSTOMER RAN SUCCESSFUL PBNP AND CK-MB CALIBRATION AND QC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826281 COBAS E 411 IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 RACK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR