BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS Z 480 ANALYZER

    MDR report key: 10025739 · Received May 5, 2020

    Report

    Report Number
    2243471-2020-00009
    Event Type
    Malfunction
    Date Received
    May 5, 2020
    Date of Event
    March 19, 2020
    Report Date
    December 3, 2020
    Manufacturer
    STACIE-ANN CREIGHTON
    Product Code
    MAQ
    PMA / PMN Number
    P100020
    Removal / Correction Number
    2243471-11-19-2020-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL STUDIES CONFIRMED THAT IMPROPER SEALING OF THE AD-PLATE CONTRIBUTES TO DIRTY LENSES. ALTHOUGH DIRTY LENSES WERE OBSERVED IN THESE STUDIES, SPATIAL CROSS-TALK AND FALSE POSITIVE/INVALID RESULTS WERE NOT REPRODUCED. THESE OBSERVATIONS SUGGEST THAT DIRTY LENSES DUE TO IMPROPER SEALING OF THE AD-PLATE ALONE DO NOT CAUSE SPATIAL CROSS-TALK AND FALSE POSITIVE RESULTS. THERE ARE LIKELY ADDITIONAL FACTORS, INCLUDING AGE AND USAGE OF THE INSTRUMENT AS WELL AS LABORATORY ENVIRONMENTAL CONDITIONS, THAT CONTRIBUTE TO DIRTY LENSES, SPATIAL CROSS-TALK AND FALSE POSITIVE/INVALID RESULTS. AFFECTED CUSTOMERS WERE NOTIFIED. SITE VISITS WILL BE SCHEDULED TO INSPECT THE OPTICAL LENS IN THE COBAS Z 480 ANALYZER DETECTION UNIT AND CLEAN, IF NECESSARY. CN-516475.

    Additional Manufacturer Narrative · 1

    THE LENS OF THE OPTICAL UNIT ON THE COBAS Z 480 AT THE CUSTOMER SITE WAS CLEANED, AND POST-REPAIR CHECKS PASSED. THROUGH THE INVESTIGATION, IT WAS IDENTIFIED THAT THE SPATIAL CROSS-TALK PHENOMENON FROM TRUE POSITIVE WELLS COULD BE SCATTERED TO THE ADJACENT WELLS DUE TO A DIRTY COBAS Z 480 LENS, CAUSING FALSE POSITIVE RESULTS UNDER SPECIFIC CONDITIONS. THE INVESTIGATION IS ON-GOING. CORRECTIVE AND PREVENTIVE ACTIONS WILL BE IMPLEMENTED AS APPROPRIATE. AN HEALTH HAZARD EVALUATION WAS PERFORMED FOR THIS SITUATION AND IT INDICATED THERE WAS A REMOTE PROBABILITY OF MEDICALLY REVERSIBLE/TRANSIENT HARM. NO HARM OR INJURY WAS REPORTED THROUGH THIS CASE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED ISSUES WITH RESULTS GENERATED WHEN RUNNING THE UDF (USER DEFINED WORKFLOW; NON-IVD WORKFLOW) ON THE COBAS Z 480 ANALYZER, A PLATE-BASED AUTOMATED AMPLIFICATION AND DETECTION SYSTEM FOR NUCLEIC ACIDS. THE CUSTOMER DID NOT PROVIDE ANY DATA FROM ACTUAL PATIENT RESULTS. RATHER, THEY PERFORMED A TEST WITH AN ALTERNATING SAMPLE SCHEME: WATER AND FLUORESCING MATERIAL IN A CHECKERBOARD PATTERN. WHEN REVIEWING THE PCR DATA IT CAN BE SEEN THAT THE SIGNAL FOR SOME POSITIONS ON THE AD PLATE (OUTER POSITIONS) IS SIGNIFICANTLY LOWER THAN THE SIGNAL OF OTHER POSITIONS (INNER POSITIONS). THIS IS AN INDICATION OF DIRTY OPTICAL LENS WITHIN THE COBAS Z 480 ANALYZER. NO HARM OR INJURY WAS INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486723 COBAS Z 480 ANALYZER KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS MAQ STACIE-ANN CREIGHTON NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1