VITEK 2 GRAM-NEGATIVE SUSCEPTIBILITY TEST KIT 413119

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-05-07 for VITEK 2 GRAM-NEGATIVE SUSCEPTIBILITY TEST KIT 413119 manufactured by Biomerieux, Inc..

Event Text Entries

[4509174] Biomerieux was contacted by (b)(4) regulatory agency, ansm, to report a discrepant cefotaxime result (false resistant) for proteus penneri (from a bone sample) on the vitek 2 ast-n234 test kit. The result provided by the vitek 2 (initial test and repeat test) was cefotaxime mic >64mg/l (r). Confirmation via etest method indicated cefotaxime mic = 1mg/l (s). Prior to reporting results to the treating physician, the patient sample was retested on the vitek 2 and confirmatory test was completed via etest. The discrepant vitek 2 results were not reported to the treating physician; however, there was a 48 hour delay in reporting results to the treating physician since testing had to be repeated and confirmed. The growth media used for the initial vitek 2 test was drigalski; for the second vitak 2 test, cps. Drigalski media has not been validated for use with the vitek 2 test kits. The customer stated the patient's therapy was not modified following the receipt of the test result (cefotaxime mic = 1mg/l s) by the clinician. The customer indicated that although reporting of the result was delayed by 48 hours, there was no adverse impact to the patient. Based on the details provided by the customer, there is no evidence/indication of the following: injury or death to patient, evidence that a patient underwent any unnecessary medical procedure due to the reported event, physician alleging the reported event caused him/her to provide incorrect treatment, evidence of negative impact to the patient due to the false resistant vitak 2 result. This event is reportable as an adverse event, as the reporting of the final ast (cefotaxime) result was delayed for 48 hours. There is no indication or report from the hospital or treating physician to biomerieux that the false resistant cefotaxime result led to an adverse event related to the patient state of health. Internal complaint investigation is in progress. This will be updated as further information becomes available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1950204-2014-00003
MDR Report Key3868727
Report Source01,05,06,07
Date Received2014-05-07
Date of Report2014-05-07
Date of Event2014-04-22
Date Mfgr Received2014-04-01
Device Manufacturer Date2014-01-03
Date Added to Maude2014-07-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactRYAN LEMELLE
Manufacturer CityHAZELWOOD MO
Manufacturer CountryUS
Manufacturer Phone3147318582
Manufacturer G1BIOMERIEUX, INC.
Manufacturer Street595 ANGLUM RD.
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal Code63042
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVITEK 2 GRAM-NEGATIVE SUSCEPTIBILITY TEST KIT
Generic NameVITEK 2 AST-N234 TEST KIT
Product CodeLTW
Date Received2014-05-07
Catalog Number413119
Lot Number634303820
Device Expiration Date2015-04-09
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX, INC.
Manufacturer AddressHAZELWOOD MO US


Patients

Patient NumberTreatmentOutcomeDate
10 2014-05-07

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