VITEK 2 GRAM-POSITIVE SUSCEPTIBILITY TEST KIT 22226

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-04-23 for VITEK 2 GRAM-POSITIVE SUSCEPTIBILITY TEST KIT 22226 manufactured by Biomerieux, Inc..

Event Text Entries

[4461231] On (b)(6) 2014, (b)(6) reported a (b)(6) using a vitek 2 gram-positive susceptibility (ast-gp67) test kit. A septic patient was tested (b)(6); gentamycin and oxacillin therapy was prescribed by the physician. The following day, blood culture was reported by a vitek 2 ast-gp67 test card as (b)(6), and the patient's treatment was changed to vancomycin. The laboratory technologist, upon noticing this change, repeated the test with a vitek 2 ast-gp67 test card and alternate method which produced (b)(6). After approximately two days of vancomycin treatment, the physician returned to the original treatment regimen of gentamycin and oxacillin. The customer indicated that although the patient treatment was changed to an antibiotic which was not optimal for a brief period, there was no adverse impact to the patient. This event is reportable as a adverse event, as the incorrect (b)(6) result influenced the physician's decision to revise therapy resulting in non-optimal treatment. Upon retesting the isolate, the ast result was (b)(6). Additional manual testing also confirmed the initial treatment prescribed by the physician was more appropriate. There is no indication or report from the hospital or treating physician to biomerieux that the (b)(6) result led to an adverse event related to the patient state of health. This event is being reported since treatment intervention was impacted in association with the (b)(6) result. The patient isolate is no longer available for testing; however, a biomerieux investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1950204-2014-00002
MDR Report Key3866784
Report Source05,06,07
Date Received2014-04-23
Date of Report2014-04-23
Date of Event2014-04-01
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 63042
Manufacturer CountryUS
Manufacturer Postal63042
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-POSITIVE SUSCEPTIBILITY TEST KIT
Generic NameVITEK 2 AST-GP67 TEST KIT
Product CodeLTW
Date Received2014-04-23
Catalog Number22226
Lot Number132312540
Device Expiration Date2015-07-05
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
101. Required No Informationntervention 2014-04-23

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