VITEK? 2 GRAM POSITIVE ID TEST KIT 21342

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-10-11 for VITEK? 2 GRAM POSITIVE ID TEST KIT 21342 manufactured by Biomerieux, Inc..

Event Text Entries

[125993220] A customer from the united states notified biom? Rieux of misidentification results between the vitek? 2 gp id card (ref 21342) and the vitek? Ms instrument. The customer reported an isolate from a blood culture was identified by a latex agglutination test as staphylococcus aureus and the susceptibility yielded a vancomycin of 4ug/ml. Etest? Was performed to confirm. The isolate was submitted to a reference lab for oritavancin testing, and was identified as a possible s. Cohnii, so the customer reevaluated the blood culture and determined the presence of three (3) morphologically different isolates. The three (3) isolates were identified as staphylococcus aureus with the vitek ms on (b)(6) 2018 in addition to vitek 2 testing in which the results did not match. Tube coagulation appeared to be positive for all isolates. The final identification from the reference lab was s. Lugdunensis, which led the customer to initially report that the vitek ms led to the misidentification. However, the isolates were submitted for internal investigation by biom? Rieux. The investigation included 16s sequencing of the isolates, which gave an identification to staphylococcus aureus. According to r&d, additional phenotypical data should be considered to select only one species. The investigation concluded on 11-sep-2018. A complaint was opened against the vitek? 2 gp id card for the following misidentifications: isolate 1 = s. Warneri (thermofisher identified this isolate as s. Lugdunensis. ) isolate 2 = low discrimination to s. Caprae, s. Cohnii ssp cohnii, s. Vitulinus. Isolate 3 = s. Lugdunensis. 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. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1950204-2018-00425
MDR Report Key7958244
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-10-11
Date of Report2019-01-15
Date Mfgr Received2018-12-18
Date Added to Maude2018-10-11
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 FDA3
Event Location3
Manufacturer ContactMS. CANDACE MARTIN
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer G1BIOMERIEUX, INC.
Manufacturer Street595 ANGLUM ROAD
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 ID TEST KIT
Generic NameVITEK? 2 GP ID TEST KIT
Product CodeLQL
Date Received2018-10-11
Catalog Number21342
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX, INC.
Manufacturer Address595 ANGLUM ROAD HAZELWOOD MO 63042 US 63042


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-11

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