BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK 2 XL BLUE MODULE COLORIMETERIC

    MDR report key: 5917113 · Received August 31, 2016

    Report

    Report Number
    1950204-2016-00113
    Event Type
    Malfunction
    Date Received
    August 31, 2016
    Report Date
    August 2, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    N50510 S082
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED IN RESPONSE TO A CUSTOMER COMPLAINT REPORTING TWO (2) OCCURRENCES IN WHICH AST-YS07 CARDS REMAINED IN THE PRELIM STATE WITH NO RESULTS REPORTED. LAB REPORTS, CARD DETAIL REPORTS, AND ISOLATE AUDIT LOGS FOR BOTH ISOLATES WERE PROVIDED. 607120294999 (15 DAYS PREVIOUSLY). LAB REPORT SHOWS LAB ID 607120294999-2. STARTED (B)(6) 2016 00:57. TIME OF ANALYSIS AS 5.25 HOURS. CARD DETAIL REPORT SHOW INITIAL READING (B)(6) 2016 20:26 AND EJECTED 1(B)(6) 2016 08:51. ISOLATE AUDIT LOG SHOWS ID CANDIDA TROPICALIS DOWNLOADED (B)(6) 2016 00:57. 607233943151 (9 DAYS PREVIOUSLY). LAB REPORT SHOWS LAB ID 607233943151-1. STARTED (B)(^) 2016 13:47 TIME OF ANALYSIS AS 11.00 HOURS. THE CARD DETAIL REPORT FOR 607233943151-1 SHOWS INITIAL READING AT (B)(6) 2016 09:26. THE CARD WAS EJECTED (B)(6) 2016 22:06. THE AUDIT LOG SHOWS LAB ID 607233943151 WAS ORIGINALLY 607233943999-1 CREATED (B)(6) 2016 09:07. ID CANDIDA ALBICANS WAS DOWNLOADED (B)(6) 2016 13:47. THIS ISOLATE WAS REDESIGNATED 607233943151 (B)(6) 2016 13:49 BY THE USER (REASON UNKNOWN). THE SUPPORT LOGS WERE REQUESTED AND SUBMITTED; HOWEVER, THE LOG FOLDER DID NOT INCLUDE THE DATES OF THE OCCURRENCES FOR THE IMPACTED ISOLATES/CARDS. OTHER AST-YS07 CARDS TESTED WERE INDICATED AS PROCESSING SUCCESSFULLY TO COMPLETION. DUE TO THE LENGTH OF TIME THAT ELAPSED BETWEEN THE INCIDENT OCCURRENCES AND COLLECTION OF THE SUPPORT LOGS FROM THE CUSTOMER SYSTEM, IT WAS NOT POSSIBLE TO DETERMINE WHY THE CARD RESULTS DID NOT PROCEED TO FINAL STATUS. THE CUSTOMER INDICATED NOT OBSERVING ANY ADDITIONAL CASES OF ISOLATES REMAINING AT PRELIM STATUS. IN ADDITION, THE CUSTOMER HAS AGREED TO MONITOR FOR AND REPORT ANY ADDITIONAL OCCURRENCES TO THE LOCAL CUSTOMER SUPPORT REPRESENTATIVE FOR POSSIBLE FURTHER ACTION OR INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMERIEUX TO REPORT THE OCCURRENCE OF DELAYED AST RESULTS FOR TWO PATIENT ISOLATES IN ASSOCIATION WITH THE VITEK 2 XL SYSTEM. THE STATUS OF THE RESULTS REMAINED AT "PRELIMINARY". THE ISOLATES WERE REPEATED; THE RESULTS REPORTED SUCCESSFULLY IN THE EXPECTED TIMEFRAME. THE CUSTOMER STATED THE DURATION OF DELAY FOR THE AST RESULTS WAS 9 AND 15 DAYS. THE CUSTOMER STATED THAT THE DELAYED RESULTS DID NOT LEAD TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S TREATMENT OR STATE OF HEALTH. INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568772 VITEK 2 XL BLUE MODULE COLORIMETERIC VITEK 2 XL LON BIOMERIEUX, INC 27227

    Patients

    Seq Age Sex Outcome Treatment
    1