BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITEK 2 GP TEST KIT

    MDR report key: 1690099 · Received May 13, 2010

    Report

    Report Number
    1950204-2010-00001
    Event Type
    Injury
    Date Received
    May 13, 2010
    Date of Event
    February 1, 2010
    Report Date
    May 13, 2010
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISOLATE IN QUESTION WAS SENT TO THE BIOMERIEUX, INC. CUSTOMER RESPONSE LAB (CRL) FOR FURTHER INVESTIGATION. WHEN THIS ISOLATE WAS INCUBATED FOR 24 HRS., ONLY PINPOINT GROWTH WAS OBSERVED; THEREFORE, THE PLATE HAD TO BE REINCUBATED FOR A LONGER PERIOD OF TIME. AT 30 HOURS THE GROWTH WAS STILL PINPOINT; HOWEVER, THREE DIFFERENT COLONY MORPHOLOGIES WERE OBSERVED SUGGESTING A MIXED CULTURE. IT WAS OBSERVED THAT THE GROWTH PATTERN FOR THIS ISOLATE WAS ATYPICAL FOR (B)(6). THE THREE DIFFERENT COLONY MORPHOLOGIES WERE SUBCULTURED AND AGAIN AFTER 24 HOURS THE GROWTH WAS TOO SCANT TO TEST THE ISOLATE ON THE VITEK 2 GP CARD (USED IN CONJUNCTION WITH THE VITEK 2 INSTRUMENT). INCUBATION CONTINUED UNTIL SUFFICIENT GROWTH WAS OBSERVED. TESTING INCLUDED THE VITEK 2 GP LOT THE CUSTOMER USED AND A RANDOM LOT MANUFACTURED NEAR THE CUSTOMER'S LOT. THE RESULTS FOR TESTING IN THE VITEK 2 GP TEST KIT WERE VARIED FROM (B)(6) TO (B)(6). DUE TO THE EXTREMELY SLOW GROWTH OF THE ISOLATE, THE APPEARANCE OF A MIXED CULTURE AND THAT 16S SEQUENCING APPEARS TO BE THE ONLY RELIABLE METHOD FOR IDENTIFYING THE ISOLATE SUGGESTS THAT IT IS NOT A GOOD CANDIDATE FOR TESTING IN A RAPID ID METHOD SUCH AS THE VITEK 2 GP CARD. THE VITEK 2 IDENTIFICATION TEST KITS CANNOT BE USED ALONE TO MAKE TREATMENT DECISIONS AND IN THIS INSTANCE THE CUSTOMER MADE AN EMPIRICAL TREATMENT DECISION ON AN ID RESULT. BASED ON THE RESULTS OF THE BIOMERIEUX INVESTIGATION AND PATIENT TREATMENT HISTORY, IT SUGGESTS THAT THE VITEK 2 GP MISID DID NOT SOLELY CAUSE OR CONTRIBUTE TO PATIENT'S ADVERSE EVENT. CURRENTLY NO FURTHER ACTIONS HAVE BEEN IDENTIFIED BY BIOMERIEUX, INC.

    Description of Event or Problem · 1

    A UNITED STATES CUSTOMER CONTACTED BIOMERIEUX, INC. ON 04/14/2010, INDICATING THAT IN (B)(6) 2010 A PATIENT HAD SEVERAL POSITIVE BLOOD CULTURE ISOLATES AFTER 3-5 DAYS. WHILE PREPARING THE ISOLATE FOR VITEK 2 GP CARD TESTING (ON THE VITEK 2 INSTRUMENT) IT WAS NOTED THAT THIS ISOLATE WAS SLOW GROWING. ON THE VITEK 2 THE ISOLATE ID'D AS (B)(6). THE TREATING PHYSICIAN QUESTIONED THE (B)(6) ID. IN (B)(6) 2009, THE SAME PATIENT WAS ADMITTED TO HOSPITAL AND A (B)(6) INFECTION WAS ID'D. (B)(6) WAS MANUALLY KEYED INTO A VITEK 2 SUSCEPTIBILITY (SUSC.) CARD AND THE ISOLATE WAS RESISTANT TO LEVOFLOXACIN. THE FEB. 2010 ISOLATE SHOWED SAME SUSC PATTERN AS THE ISOLATE FROM 2009. AS K. VARIANS IS NOT CLAIMED ON THE VITEK 2 SUSC. CARDS THE CUSTOMER TURNED TO LITERATURE AND EMPIRICALLY TREATED THE PATIENT WITH LEVOFLOXACIN AND METRONIDAZOLE DURING CONTINUED TESTING. THE LEVOFLOXACIN AND METRONIDAZOLE TREATMENT APPEARS SHORT BASED ON LAB REPORTS (THE ID AND MANUALLY KEYED SUSC TESTS WERE RUN WITHIN 2 DAYS OF EACH OTHER). THE PATIENT LATER EXPERIENCED HEART VALVE DAMAGE REQUIRING REPLACEMENT, WHICH MAY HAVE BEEN THE RESULT OF INAPPROPRIATE ANTIMICROBIAL TREATMENT WITH LEVOFLOXACIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITEK 2 GP TEST KIT GRAM POSITIVE IDENTIFICATION CARD LON BIOMERIEUX, INC. 242164740

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R