BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6800 SYSTEM

    MDR report key: 6570357 · Received May 16, 2017

    Report

    Report Number
    2243471-2017-00018
    Event Type
    Malfunction
    Date Received
    May 16, 2017
    Date of Event
    February 27, 2017
    Report Date
    March 21, 2018
    Manufacturer
    STACIE-ANN CREIGHTON
    Product Code
    MZA
    PMA / PMN Number
    BK140196
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WITHIN THE INITIAL MDR REPORT, THE BECOME AWARE DATE (DATE RECEIVED BY THE MANUFACTURER) WAS INDICATED AS 03/13/2017. AFTER REVIEW OF THE SUBMITTED MDR RECORD, IT WAS IDENTIFIED THAT THE CORRECT DATE RECEIVED BY THE MANUFACTURER SHOULD HAVE BEEN CAPTURED AS 04/19/2017. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THE ISSUE IS CURRENTLY ON-GOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AT THE CONCLUSION OF THE INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) COMPLAINED ABOUT A BARCODE ISSUE WITH THE COBAS 6800 SYSTEM. SPECIFICALLY, THE BARCODE FOR A PATIENT SAMPLE WAS SHORTENED FROM 12 DIGITS TO 11 DIGITS. THE SAMPLE HAS BEEN PROCESSED SUCCESSFULLY BUT THE RESULTS COULD NOT BE MATCHED WITH THE CUSTOMER'S LIS DUE TO THE SHORTENED BARCODE ID. AS A CONSEQUENCE, THE SAMPLE NEEDED TO BE RETESTED. NO WRONG RESULTS WERE RELEASED AND NO HARM WAS INDICATED. THROUGH THE COURSE OF THE INVESTIGATION, IT WAS IDENTIFIED THAT THE BARCODE LABEL IN QUESTION WAS NOT AFFIXED TO THE SAMPLE TUBE IN A PERPENDICULAR MANNER, AS DESCRIBED WITHIN THE USER ASSISTANCE SPECIFICATIONS. THESE OUT-OF SPECIFICATIONS BARCODE LABELS CONTRIBUTED TO THE TRUNCATED BARCODE READING ISSUE ALLEGED IN THIS CASE. ADDITIONALLY, CAPA HAS BEEN INITIATED AND CORRECTIVE AND PREVENTIVE ACTIONS WILL BE IMPLEMENTED AS APPROPRIATE. A HEALTH HAZARD EVALUATION WAS PERFORMED AND IT WAS DETERMINED THAT THE SITUATION IS NOT LIKELY TO CAUSE SERIOUS ADVERSE HEALTH CONSEQUENCES BASED THE VERY LOW OCCURRENCE RATE FOR A BARCODE TRUNCATION EVENT AND THE PROBABILITY OF A SAMPLE MISMATCH EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER IN GERMANY COMPLAINED ABOUT A BARCODE ISSUE WITH THE COBAS 6800 SYSTEM. SPECIFICALLY, THE BARCODE FOR A PATIENT SAMPLE WAS SHORTENED FROM 12 DIGITS TO 11 DIGITS. AS THE SAMPLE IS TRACKED WITH THE INCORRECT BARCODE ID IN THE SYSTEM SOFTWARE THERE IS A POSSIBILITY THAT THIS CAN LEAD TO A SAMPLE MISMATCH OR THE ASSIGNMENT OF A RESULT TO THE WRONG PATIENT. THE CUSTOMER DID NOT REPORT THAT THIS DID OCCUR DURING THEIR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350526 COBAS 6800 SYSTEM AUTOMATED BLOODBORNE PATHOGEN TEST EQUIPMENT MZA STACIE-ANN CREIGHTON NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1