BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUIOS CL FLOW CYTOMETER

    MDR report key: 7000643 · Received November 3, 2017

    Report

    Report Number
    1061932-2017-00017
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    October 20, 2017
    Report Date
    October 24, 2017
    Manufacturer
    BECKMAN COULTER IRELAND INC.
    Product Code
    OYE
    UDI-DI
    15099590225889
    PMA / PMN Number
    K141932
    Removal / Correction Number
    2050012-0928/2017-022C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED SCREEN SHOTS OF THE INSTRUMENT SETTINGS AND LOGS THAT WERE USED FOR A PRELIMINARY ASSESSMENT OF THE EVENT. THE BECKMAN COULTER (BEC) SOFTWARE ENGINEERING TEAM REVIEWED THE AVAILABLE INFORMATION AND FOUND TWO SAMPLE ID NUMBERS THAT ARE SUSPECTED TO BE ERRONEOUS ((B)(6)). ADDITIONAL SOFTWARE DATA HAS BEEN REQUESTED FOR A COMPREHENSIVE ASSESSMENT OF THE ISSUE.. ON (B)(6) 2017, THE CUSTOMER WAS CONTACTED VIA TELEPHONE TO DISCUSS THE EVENT AND INFORM THEM OF THE TWO POTENTIAL SAMPLE MISIDENTIFICATIONS. THE CUSTOMER (DR. (B)(6)) REVIEWED HIS RECORDS AND CONFIRMED THAT THE RESULTS FOR PATIENT ID (B)(6) WERE REVIEWED AS CORRECT AND THAT THE RESULTS FOR PATIENT ID (B)(6) HAD BEEN CONSIDERED INCORRECT UPON REVIEW AND THE PATIENT SAMPLE WAS RERUN. THE ORIGINAL ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LAB. IN THE SAME CONVERSATION THE CUSTOMER HAS AGREED TO ALLOW A BEC SOFTWARE SPECIALIST TO ACCESS THEIR DATABASE FOR FURTHER ASSESSMENT. THE BEC SOFTWARE SPECIALIST IS SCHEDULED TO GO TO THE CUSTOMER SITE THE WEEK OF NOVEMBER 06, 2017. ADDITIONAL SOFTWARE DATA HAS BEEN REQUESTED FROM THE CUSTOMER IN ORDER TO COMPLETE A COMPREHENSIVE ASSESSMENT OF THE ISSUE. BASED ON THE INFORMATION AVAILABLE, THE ASSIGNABLE CAUSE IS AN AQUIOS CL SOFTWARE MALFUNCTION. PATIENT AGE IS UNKNOWN. PATIENT SEX IS UNKNOWN. PATIENT WEIGHT IS UNKNOWN. PATIENT ETHNICITY IS UNKNOWN. PATIENT RACE IS UNKNOWN. BEC INTERNAL IDENTIFIER - (B)(6).

    Additional Manufacturer Narrative · 1

    REPORTING NUMBER UPDATED TO REFLECT CORRECT NUMBER.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED SCREEN SHOTS OF THE INSTRUMENT SETTINGS AND LOGS THAT WERE USED FOR A PRELIMINARY ASSESSMENT OF THE EVENT. THE BECKMAN COULTER (BEC) SOFTWARE ENGINEERING TEAM REVIEWED THE AVAILABLE INFORMATION AND FOUND TWO SAMPLE ID NUMBERS THAT ARE SUSPECTED TO BE ERRONEOUS ((B)(6)). ADDITIONAL SOFTWARE DATA HAS BEEN REQUESTED FOR A COMPREHENSIVE ASSESSMENT OF THE ISSUE. ON (B)(6), 2017, THE CUSTOMER WAS CONTACTED VIA TELEPHONE TO DISCUSS THE EVENT AND INFORM THEM OF THE TWO POTENTIAL SAMPLE MISIDENTIFICATIONS. THE CUSTOMER (DR. (B)(6)) REVIEWED HIS RECORDS AND CONFIRMED THAT THE RESULTS FOR PATIENT ID (B)(6) WERE REVIEWED AS CORRECT AND THAT THE RESULTS FOR PATIENT ID (B)(6) HAD BEEN CONSIDERED INCORRECT UPON REVIEW AND THE PATIENT SAMPLE WAS RERUN. THE ORIGINAL ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LAB. IN THE SAME CONVERSATION THE CUSTOMER HAS AGREED TO ALLOW A BEC SOFTWARE SPECIALIST TO ACCESS THEIR DATABASE FOR FURTHER ASSESSMENT. THE BEC SOFTWARE SPECIALIST IS SCHEDULED TO GO TO THE CUSTOMER SITE THE WEEK OF (B)(6), 2017. ADDITIONAL SOFTWARE DATA HAS BEEN REQUESTED FROM THE CUSTOMER IN ORDER TO COMPLETE A COMPREHENSIVE ASSESSMENT OF THE ISSUE. BASED ON THE INFORMATION AVAILABLE, THE ASSIGNABLE CAUSE IS AN AQUIOS CL SOFTWARE MALFUNCTION. BEC INTERNAL IDENTIFIER - (B)(4). ADDITIONAL INFORMATION - FOLLOW-UP REPORT 01: A BECKMAN COULTER SOFTWARE ENGINEER ARRIVED AT THE CUSTOMER SITE ON 15-NOV-2017. THE CUSTOMER'S DATABASE WAS RETRIEVED AND ANALYZED FOR DATA FROM THE DATE OF EVENT TO PRESENT. INITIAL ANALYSIS ON SITE SHOWED THAT THERE WERE DUPLICATE SAMPLE ID EVENTS ON (B)(6) 2017 MIS-IDENTIFIED SAMPLES AND ELEVEN (11) SUSPICIOUS SAMPLES. FURTHER ANALYSIS AND INVESTIGATION OF THE ENTIRE DATABASE IS ONGOING. THE CUSTOMER HAS TURNED OFF THE AUTO-RELEASE FEATURE AND IS REVIEWING EACH RESULT BEFORE RELEASING IT TO THE LABORATORY INFORMATION SYSTEM (LIS). THE RECALL (FA-31978) WHICH INCLUDED NOTIFICATION TO THE CUSTOMER AND INSPECTION OF CUSTOMERS' DEVICE DATA WILL BE UPDATED VIA ADDITIONAL COMMUNICATION TO CUSTOMERS TO ADDRESS THIS NEW FAILURE MODE. UPDATED RECALL TO BE INITIATED THE WEEK OF (B)(6) 2017. THE LEGAL MANUFACTURER INFORMATION HAS BEEN CORRECTED IN THIS REPORT TO BECKMAN COULTER IRELAND INC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LABORATORY HAD FOLLOWED THE FIELD SAFETY NOTICE FSN-31978 INSTRUCTIONS AND UPDATED THE INSTRUMENT SETTINGS ON (B)(6) 2017. THE CUSTOMER REPORTED DUPLICATE SAMPLE REQUESTS BEING GENERATED BY THEIR AQUIOS CL ON (B)(6) 2017, AND THAT IT SEEMS THE CHANGE TO THE SETTINGS WAS NOT EFFECTIVE. THE CUSTOMER DID NOT IDENTIFY ANY ERRONEOUS RESULTS AT THE TIME OF DISCOVERY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LABORATORY HAD FOLLOWED THE FIELD SAFETY NOTICE FSN-31978 INSTRUCTIONS AND UPDATED THE INSTRUMENT SETTINGS ON (B)(6), 2017. THE CUSTOMER REPORTED DUPLICATE SAMPLE REQUESTS BEING GENERATED BY THEIR AQUIOS CL ON (B)(6), 2017, AND THAT IT SEEMS THE CHANGE TO THE SETTINGS WAS NOT EFFECTIVE. ADDITIONAL INFORMATION - FOLLOW-UP REPORT 01: THIS REPORT (1061932-2017-00017) REFERS TO THE EVENT THAT TOOK PLACE ON THE DATE OF EVENT. RELATED REPORT 1061932-2017-00020 REFERS TO THE EVENT THAT TOOK PLACE (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779653 AQUIOS CL FLOW CYTOMETER FLOW CYTOMETER OYE BECKMAN COULTER IRELAND INC. B30166 NA 15099590225889

    Patients

    Seq Age Sex Outcome Treatment
    1