BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8800 SYSTEM

    MDR report key: 7195239 · Received January 16, 2018

    Report

    Report Number
    2243471-2018-00001
    Event Type
    Malfunction
    Date Received
    January 16, 2018
    Date of Event
    December 12, 2017
    Report Date
    March 14, 2018
    Manufacturer
    STACIE-ANN CREIGHTON
    Product Code
    MZA
    PMA / PMN Number
    BK140195
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SHOWED THAT THE SITUATION OF A PARTIALLY DETACHED COBAS OMNI PIPETTE TIP (P-TIP) WAS CONTRIBUTED BY A DEFECTIVE TIP WHERE PLASTIC FIBERS WERE PRESENT AT THE INNER WALL OF THE PIPETTE, WHICH INTERFERED WITH THE PICKUP AND DISPOSAL OF THE TIP. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SUPPLIER OF THE TIPS. THE SUPPLIER HAS MADE CORRECTIONS IN THE PRODUCTION PROCESS TO AVOID CREATION OF SUCH PLASTIC FIBERS, AND THE SCAR IS ONGOING. THE MATERIAL THAT CONTRIBUTED TO THIS ISSUE IS THE "COBAS OMNI PIPETTE TIPS"; CATALOG NO: 05534925001; (B)(4). FURTHER INVESTIGATION INTO THE ISSUE SHOWED THE COBAS 6800/8800 INSTRUMENT HAS A LIMITED MECHANISM TO DETECT PARTIALLY ATTACHED P-TIPS. THE INTERNAL TEST WAS DONE USING VARIOUS HEIGHTS OF PARTIALLY DETACHED TIPS. IT SHOWED THAT THE INSTRUMENT SENSOR DETECTS A TIP AT SPECIFIC HEIGHTS WHEN DETACHED FROM THE SAMPLE TRANSFER HEAD. WHEN THE DISTANCE OF THE PARTIALLY DETACHED P-TIP TO THE SENSOR IS TOO FAR, THE INSTRUMENT SENSOR WOULD NOT DETECT THE PRESENCE OF THE P-TIP. THE ISSUE WAS NOT REPRODUCED WHEN USING A DEFECTIVE P-TIP, BUT RATHER BY MANUAL MODIFICATION ON THE HEIGHT OF ATTACHED TIPS. AN INTERNAL CHANGE HAS INITIATED TO ADDRESS THE LIMITATION IN THE SURVEILLANCE FOR ATTACHED TIPS. A HEALTH HAZARD EVALUATION CONCLUDED THAT THIS SITUATION IS UNLIKELY TO CAUSE ANY SEVERE ADVERSE HEALTH CONSEQUENCES. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THIS ISSUE IS CURRENTLY ON-GOING. THE OUTCOME OF THIS INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. THE UDI FOR THE COBAS 8800 SYSTEM IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6), REPORTED THAT THE COBAS 8800 SYSTEM STOPPED AND WENT INTO AN "ERROR" STATE DURING A RUN AS A PROCESSING TIP REMAINED ATTACHED TO THE SAMPLE TRANSFER HEAD DUE TO A DEFECT IN THE TIP, WHICH KEPT IT STUCK ON THE SAMPLE TRANSFER HEAD. AS NO ERROR EVENT WAS GENERATED ON THE FAILED TIP EJECTION, THE STUCK PROCESSING TIP WAS RE-USED BY THE COBAS 8800 SYSTEM TO PIPETTE ANOTHER SAMPLE FROM A DIFFERENT DONOR TUBE. WHEN ATTEMPTING TO DISPOSE THIS RE-USED PROCESSING TIP, THE COBAS 8800 SYSTEM WENT INTO AN "ERROR" STATE AND THE RUN WAS NOT COMPLETED. THE RE-USE OF A PROCESSING TIP COULD POTENTIALLY LEAD TO CONTAMINATION OF A CLINICAL SPECIMEN; HOWEVER, NO CONTAMINATION EVENT OCCURRED AT THE CUSTOMER SITE AND THERE WAS NO INDICATION OF HARM OR INJURY TO ANY DONOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40888 COBAS 8800 SYSTEM AUTOMATED BLOODBORNE PATHOGEN TEST EQUIPMENT MZA STACIE-ANN CREIGHTON NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1