BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-P656 TEST KIT

    MDR report key: 8173836 · Received December 18, 2018

    Report

    Report Number
    1950204-2018-00704
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Report Date
    May 10, 2019
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    K053097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR A CUSTOMER IN (B)(6) REPORTING A FALSE NEGATIVE CEFOXITIN SCREEN FOR FOUR STAPHYLOCOCCUS AUREUS STRAINS FROM ONE PATIENT IN ASSOCIATION WITH THE VITEK® 2 AST-P656 TEST KIT. THE CUSTOMER REPORTED THAT ALL FOUR ISOLATES (BLOOD, HIP FLUID/TISSUE) WERE CEFOXITIN SCREEN TEST(OXSF) NEGATIVE AND OXACILLIN (OX) SUSCEPTIBLE (WITH ONE RESISTANT RESULT), WITH VARYING OX MICS RANGING FROM <= 0.25 TO >= 4. PCR TESTING IDENTIFIED THAT ALL STRAINS WERE MECA POSITIVE. THE OXACILLIN DISK TESTING WAS RESISTANT (18MM). THREE STRAINS WERE SUBMITTED FOR INVESTIGATION. THE THREE SUBMITTED STRAINS WERE SUBCULTURED, AND IDENTIFICATIONS WERE CONFIRMED AS S. AUREUS. VITEK 2 TESTING WAS PERFORMED WITH SOFTWARE V8.01, AND AST-P656 CARDS FROM THE CUSTOMER'S LOT (8060516203) AND A RANDOM LOT (8060858203). TESTING INCLUDED OX AGAR DILUTION (AD), AND CEFOXITIN DISK DIFFUSION AS THE REFERENCE METHODS FOR OX101N AND OXSF101N FORMULATIONS FOUND ON THIS CARD, AND ALERE PBP2. FOR ALL THREE ISOLATES 911934 (BH 318-0351), 911935 (BH 318- 0352) AND 911936 (BH 318-0353) TEST RESULTS WERE THE SAME ON ALL AST-P656 CARDS TESTED. OX MIC = 2, OXSF TESTS NEGATIVE, OX AD MIC = 4. CEFOXITIN DISC DIFFUSION WAS BORDERLINE RESISTANT AT 20 MM. PBP2A TESTS WERE POSITIVE. VITEK 2 OXACILLIN MIC'S ARE WITHIN ONE DOUBLING DILUTION WITH THE REFERENCE METHOD DEMONSTRATING ESSENTIAL AGREEMENT WITH VERY MAJOR CATEGORY ERROR FOR THESE BORDERLINE STRAINS. THE NEGATIVE OXSF RESULTS ARE NOT IN AGREEMENT WITH THE REFERENCE METHOD, ALSO DEMONSTRATING BORDERLINE RESISTANCE. THE CUSTOMER'S VARIABILITY OF OX MIC'S WAS NOT DUPLICATED AND THE RESULTING OXACILLIN MICS = 2 TRIGGERED THE BIOART RULE WARNING OF POSSIBLE LOW LEVEL RESISTANCE FOR THESE STRAINS. OXACILLIN RESULTS ARE IN ESSENTIAL AGREEMENT WITH REFERENCE WHILE FALSE NEGATIVE OXSF RESULTS ARE REPRODUCED WITH THESE BORDERLINE STRAINS DEMONSTRATING LOW LEVEL RESISTANCE

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A FALSE NEGATIVE CEFOXITIN SCREEN FOR FOUR STAPHYLOCOCCUS AUREUS STRAINS FROM ONE PATIENT IN ASSOCIATION WITH THE VITEK® 2 AST-P656 TEST KIT. THE CUSTOMER REPORTED THAT ALL FOUR ISOLATES (BLOOD, HIP FLUID/TISSUE) WERE CEFOXITIN SCREEN NEGATIVE AND (B)(6). PCR TESTING IDENTIFIED THAT ALL STRAINS WERE (B)(6). THE OXACILLIN DISK TESTING WAS RESISTANT (18MM). THE CUSTOMER STATED THE INCORRECT RESULT WAS SENT TO THE CLINICIAN, AND IT WAS UNKNOWN IF PATIENT TREATMENT WAS IMPACTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015333 VITEK® 2 AST-P656 TEST KIT VITEK® 2 AST-P656 TEST KIT LON BIOMERIEUX, INC. 8060516203

    Patients

    Seq Age Sex Outcome Treatment
    1