BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-GP75 TEST KIT

    MDR report key: 8158208 · Received December 12, 2018

    Report

    Report Number
    1950204-2018-00644
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Report Date
    February 21, 2019
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    UDI-DI
    03573026437183
    PMA / PMN Number
    N50510: S117
    Removal / Correction Number
    4215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS PERFORMED FALSE RESISTANT OXACILLIN (OX) RESULTS FOR TWO STAPHYLOCOCCUS AUREUS STRAINS IN ASSOCIATION WITH THE VITEK 2 AST-GP75 CARD AND SOFTWARE V7.01. THE SUBMITTED CUSTOMER STRAINS WERE SUBCULTURED TO TSAB AGAR, AND THE IDENTIFICATIONS WERE CONFIRMED AS S. AUREUS. TESTING INCLUDED AST-GP75 CARDS FROM THE CUSTOMER'S LOT (2750809103) AND A RANDOM LOT (2750712403), AGAR DILUTION (AD) AND CEFOXITIN DISK DIFFUSION AS THE REFERENCE METHODS FOR OX101N AND OXSF101N FORMULATIONS FOUND ON THIS CARD, AS WELL AS ALERE PBP2. VITEK 2 TESTING WAS PERFORMED WITH SOFTWARE V7.01 AND V8.01. 911826 (BL-18-026429): ALL FOUR GP75 CARDS TESTED RESULTED IN MICS = 0.5 AND NEGATIVE CEFOXITIN SCREEN TESTS WITH SOFTWARE V7.01 AND V8.01. OX AD MIC = 0.5, CEFOXITIN DISC DIFFUSION SUSCEPTIBLE (26MM) AND PBP2 TESTING WAS NEGATIVE. VITEK 2 TEST RESULTS ARE IN EXACT AGREEMENT WITH THE REFERENCE METHODS FOR THIS STRAIN. 911827 (TS-18-003541): ALL FOUR GP75 CARDS TESTED RESULTED IN MICS >/= 4 AND NEGATIVE CEFOXITIN SCREEN TESTS WITH AES PROPOSED MODIFICATIONS TO POSITIVE WITH SOFTWARE V7.01 AND V8.01. OX AD MIC = 2, CEFOXITIN DISC DIFFUSION SUSCEPTIBLE (26MM) AND PBP2 TESTING WAS NEGATIVE. CARDS AND REFERENCE METHOD ARE IN AGREEMENT FOR THE OXSF TEST. VITEK 2 OX TEST RESULTS ARE IN ESSENTIAL AGREEMENT WITH THE REFERENCE METHOD WITH A MAJOR CATEGORY ERROR FOR THIS BORDERLINE STRAIN. VITEK 2 CARDS ARE IN AGREEMENT AND ESSENTIAL AGREEMENT WITH REFERENCE METHODS FOR THESE TWO STRAINS. A FIELD SAFETY CORRECTIVE ACTION (FSCA 4215) WAS ISSUED 11JAN2019 AND SENT TO CUSTOMERS WHO RECEIVED ANY OF THE CARD LOTS MANUFACTURED USING POUCHER 1 DURING THE IMPLICATED TIMEFRAME. THE COMMUNICATION WILL INCLUDE INCLUDED INSTRUCTIONS FOR LOCATING THE POUCHER NUMBER ON THE CARD POUCH AND FOR INSPECTING THE POUCH TOP SEAL TO IDENTIFY POUCHES WITH INEFFECTIVE SEALS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A (B)(6) RESULTS FOR TWO STAPHYLOCOCCUS AUREUS STRAINS IN ASSOCIATION WITH THE VITEK® 2 AST-GP75 TEST KIT. THE CUSTOMER STATED THEY HAD TWO ISOLATES (BLOOD AND TISSUE) FROM TWO PATIENTS, WITH A NEGATIVE CEFOXITIN SCREEN AND (B)(6). THE CUSTOMER STATED THE VITEK AES SOFTWARE CHANGED THE CEFOXITIN SCREEN TO RESISTANT BASED ON THE (B)(6) RESULT. THE CUSTOMER PERFORMED (B)(6) TESTING AND IT WAS (B)(6). ONE ISOLATE WAS ALSO (B)(6) WITH PB2 TUBE PROTEIN BINDING. THE CUSTOMER STATED THE QC WAS CONFORMING. THE REPEAT TEST WITH THE AST-GP75 CARD WAS (B)(6). THE CUSTOMER STATED THERE WAS NO INCORRECT RESULT REPORTED TO THE PHYSICIAN, AND NO IMPACT TO PATIENT. 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
    996465 VITEK® 2 AST-GP75 TEST KIT VITEK® 2 AST-GP75 TEST KIT LON BIOMERIEUX, INC. 2750809103 03573026437183

    Patients

    Seq Age Sex Outcome Treatment
    1