BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK 2 GRAM-NEGATIVE SUSCEPTIBILITY TEST KIT AST-N340

    MDR report key: 6292331 · Received February 1, 2017

    Report

    Report Number
    1950204-2017-00040
    Event Type
    Malfunction
    Date Received
    February 1, 2017
    Report Date
    August 2, 2017
    Manufacturer
    BIOMÉRIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    N50510: S 82
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: THIS INVESTIGATION WAS INITIATED DUE TO FALSE SUSCEPTIBLE CEFTAZIDIME (CAZ) RESULTS ON VITEK®2 V7.01 AST-N340 CARD FOR 4 STRAINS OF KLEBSIELLA PNEUMONIAE. BIOMÉRIEUX PERFORMED THE AGAR DILUTION (AD) TO DETERMINE THE INTENDED RESULT (METHOD USED FOR CAZ01N AND AMC01N DEVELOPMENT ON VITEK® 2 ON AST-N340). IN PARALLEL, BIOMÉRIEUX TESTED VITEK®2 CARDS AST-N340 (V7.01): 1 CUSTOMER LOT (CL) 7800160103 AND 1 RANDOM LOT (RL) 7800257103, AND RESULTS WERE COMPARED. INTERPRETATION ACCORDING TO: BREAKPOINTS VITEK®2 V7.01 CASFM EUCAST 2015 ENTEROBACTERIACEAE - CEFTAZIDIME [S LESS THAN OR EQUAL TO 1; R > 4]. STRAIN S1: CAZ: THE REFERENCE MICS (AD) ARE: 0.125 MG/L (S) FROM MASS AND 16 MG/L (R) FROM INDUCED COLONY. ON BOTH LOTS TESTED OF AST-N340 CARD, MICS ARE LESS THAN OR EQUAL TO 1 MG/L (S) FROM MASS AND GREATER THAN OR EQUAL TO 64 MG/L (R) FROM INDUCED COLONY. FOR S1 MASS, THE VITEK®2 RESULTS FOR CAZ IS IN ESSENTIAL AGREEMENT WITH THE REFERENCE RESULTS, AND NO CATEGORY ERROR. FOR S1 INDUCED COLONY: FOR CAZ, THE VITEK®2 RESULTS ARE IN ESSENTIAL AGREEMENT ERROR COMPARED TO THE REFERENCE RESULTS, WITHOUT CATEGORY ERROR. VITEK®2 RESULTS ARE CORRELATED TO THE REFERENCE METHOD. STRAIN S2: CAZ: THE REFERENCE MICS (AD) ARE 0.5 MG/L (S) FROM MASS AND 8 MG/L (R ) FROM INDUCED COLONY. ON BOTH LOTS TESTED OF AST-N340 CARD, MICS ARE LESS THAN OR EQUAL TO 1MG/L (S) FROM MASS AND 2 MG/L (I) FROM INDUCED COLONY. INTERPRETATION: FOR S2 MASS, THE VITEK®2 RESULTS FOR CAZ IS IN ESSENTIAL AGREEMENT WITH THE REFERENCE RESULTS, WITHOUT CATEGORY ERROR. FOR S2 INDUCED COLONY: FOR CAZ, THE VITEK®2 RESULTS ARE IN ESSENTIAL AGREEMENT ERROR COMPARED TO THE REFERENCE RESULTS, LEADING TO A MINOR ERROR. STRAIN S3: CAZ: THE REFERENCE MICS (AD) ARE 0.5 MG/L (S) FROM MASS AND 8 MG/L (R ) FROM INDUCED COLONY. ON AST-N340 CARD: FROM MASS MICS ARE LESS THAN OR EQUAL TO 1MG/L (S) ON BOTH LOTS. FROM INDUCED COLONY: MIC = 4 MG/L (I) ON CL AND MIC = 2 MG/L (I) ON RL. INTERPRETATION: FOR S3 MASS, THE VITEK®2 RESULTS FOR CAZ IS IN ESSENTIAL AGREEMENT WITH THE REFERENCE RESULTS, AND NO CATEGORY ERROR. FOR S3 INDUCED COLONY: FOR CAZ, THE VITEK®2 RESULTS (CL) ARE IN ESSENTIAL AGREEMENT WITHIN 1 DOUBLING DILUTION WITH THE REFERENCE RESULTS, BUT PRESENCE OF A MINOR ERROR AND VITEK®2 RESULTS (RL) ARE IN ESSENTIAL AGREEMENT ERROR COMPARED TO THE REFERENCE RESULTS, LEADING TO A MINOR ERROR. STRAIN S4: CAZ: THE REFERENCE MICS (AD) ARE 0.5 MG/L (S) FROM MASS AND 16 MG/L (R ) FROM INDUCED COLONY. ON BOTH LOTS TESTED OF AST-N340 CARD, MICS ARE FROM MASS MICS ARE LESS THAN OR EQUAL TO 1MG/L (S) AND GREATER THAN OR EQUAL TO 64 MG/L (R) FROM INDUCED COLONY. INTERPRETATION: FOR S4 MASS, THE VITEK®2 RESULTS FOR CAZ IS IN ESSENTIAL AGREEMENT WITHIN 1 DOUBLING DILUTION COMPARED TO THE REFERENCE RESULTS, AND NO CATEGORY ERROR. FOR S4 INDUCED COLONY: FOR CAZ, THE VITEK®2 RESULTS ARE IN ESSENTIAL AGREEMENT ERROR WITH THE REFERENCE RESULTS, WITHOUT CATEGORY ERROR. CONCLUSION: THE RESULTS SHOW THE PRESENCE OF TWO POPULATIONS IN EACH OF THE FOUR ISOLATES. THE RESISTANT POPULATION CAN BE OBSERVED AFTER SELECTION ONLY. BIOMÉRIEUX DUPLICATED THE SUSCEPTIBLE CUSTOMER VITEK®2 RESULTS FOR ALL THE NATIVE ISOLATES (WITHOUT SELECTION) RECEIVED, WITH MICS WELL CORRELATED TO THE REFERENCE METHOD (AGAR DILUTION). AST-N340 PERFORMED AS INTENDED AND IS ALSO ABLE TO DETECT THE RESISTANCES AFTER RECOVERY OF THE RESISTANT POPULATION. THE DISCREPANCIES OBTAINED BETWEEN METHODS AT THE CUSTOMER LAB MAY BE A RESULT OF TESTING PERFORMED AT DIFFERENT TIMES.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED THE OCCURRENCE OF FALSE SUSCEPTIBLE CEFTAZIDIME (MIC <= 1) RESULT FOR KLEBSIELLA PNEUMONIAE IN ASSOCIATION WITH THE VITEK® 2 AST-N340 TEST KIT. REPEAT TEST OBTAINED THE SAME RESULT. THE CEFTAZIDIME RESULT VIA DISK DIFFUSION METHOD WAS RESISTANT. NOTE: THOUGH THE AST-N340 TEST KIT IS NOT MARKETED OR SOLD IN THE UNITED STATES, CEFTAZIDIME ANTIBIOTIC IS REGISTERED WITH THE FDA AND IS CONTAINED ON OTHER VITEK® 2 TEST KITS THAT ARE MARKETED AND SOLD IN THE UNITED STATES. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. CULTURE SUBMITTAL WAS REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77158 VITEK 2 GRAM-NEGATIVE SUSCEPTIBILITY TEST KIT AST-N340 VITEK 2 AST-N340 LON BIOMÉRIEUX, INC. 7800160103

    Patients

    Seq Age Sex Outcome Treatment
    1