BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2243471-2019-00013

    MDR report key: 8440123 · Received March 21, 2019

    Report

    Report Number
    2243471-2019-00013
    Event Type
    Malfunction
    Date Received
    March 21, 2019
    Date of Event
    January 26, 2019
    Report Date
    March 21, 2019
    PMA / PMN Number
    BK140195
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THE CUSTOMER'S INSTRUMENT (SERIAL ID SN-(B)(4)), ALL STOP DISCS AND O-RINGS WERE REPLACED ON PROCESSING MODULE B ON THE 15 JANUARY 2019, AND ARE PLANNED TO BE REPLACED ON THE PROCESSING MODULE A. THE MATERIAL HAS BEEN REQUESTED BACK FOR FURTHER INVESTIGATION WITH THE SUPPLIER. THE DROPLETS OBSERVED AROUND THE HEATING STATIONS WERE CLEANED BY THE LOCAL FIELD SERVICE ENGINEER. CORRECTIVE AND PREVENTIVE ACTIONS WILL BE IMPLEMENTED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    A (B)(6) FIELD SERVICE ENGINEER (FSE) PERFORMED A TIGHTNESS CHECK ON A CUSTOMER'S COBAS 8800 SYSTEM (SERIAL ID (B)(4)), WHICH FAILED FOR PROCESSING MODULE A, ON (B)(6) 2019. SUBSEQUENT CHECKS ON THIS SYSTEM PASSED ON (B)(6) 2019. REVIEW OF CUSTOMER-PROVIDED DATA SHOWED ONE (1) P07P ERROR CODE WAS GENERATED FOR A SAMPLE PROCESSED ON THE COBAS 8800 SYSTEM PROCESSING MODULE A ON (B)(6) 2019; THE ERROR CODE P07P IS INDICATIVE OF A VOLUME ERROR DURING SUPERNATANT REMOVAL. WHEN ERROR CODES ARE GENERATED FOR SAMPLES, THE SAMPLES ARE INVALIDATED AND NEED TO BE REPEAT TESTED PER THE INSTRUCTIONS FOR USE. ADDITIONALLY, IMAGES ON THE PROCESSING MODULE DECKS WERE PROVIDED AND SHOWED EVIDENCE OF LEAKAGE/DROPLETS ON THE FRONT HEATING STATION. NO HARM OR INJURY WAS ALLEGED WITHIN THE CASE.

    Patients

    Seq Age Sex Outcome Treatment
    1