FDA.reportPublic FDA data

MAUDE MDR 6749768

MDR report key
6749768
Report number
3002769706-2017-00212
Event key
0
Event type
3
Date received
2017-07-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. ELLEN WELTMER
Address
595 ANGLUM ROAD SAINT LOUIS MO 63042 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CHROMID? VRE ID AGARCHROMID? VRE ID AGARBIOMERIEUX SAJSO430041005580260R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-280

Event Narratives#

D

Patient 1

A CUSTOMER IN (B)(6) NOTIFIED BIOM?RIEUX OF DISCREPANT RESULTS ASSOCIATED WITH CHROMID? VRE ID AGAR (REFERENCE (B)(4)). THE CUSTOMER REPORTED THAT THE MEDIA HAD A BAD SELECTIVITY FOR SUSCEPTIBLE VANCOMYCIN ENTEROCOCCI. THE CUSTOMER PROVIDED FIVE (5) EXAMPLES THAT RESULTED IN FALSE POSITIVE RESULTS. THE SAMPLES WERE COLLECTED FROM THE RECTAL REGION FOR VRE SCREENING. THE PLATES WERE STREAKED DIRECTLY FROM THE COLLECTED RECTAL SWAB AND INCUBATED FOR 24 - 48 HOURS. RESULTS WERE AS FOLLOWS: SAMPLE A: GROWTH ON VRE AGAR AFTER 48 H INCUBATION, VITEK 2 SUSCEPTIBLE (MIC 1) NO ETEST RESULT. SAMPLE B: GROWTH ON VRE AGAR AFTER 48 H INCUBATION, VITEK 2 SUSCEPTIBLE (MIC 1) VA-ETEST = 1,0 ?G/ML (S). SAMPLE C: GROWTH ON VRE AGAR AFTER 24 H INCUBATION, VITEK 2 SUSCEPTIBLE (MIC 2) VA-ETEST = 2,0 ?G/ML (S). SAMPLE D: GROWTH ON VRE AGAR AFTER 24 H INCUBATION, VITEK 2 SUSCEPTIBLE (MIC 2) VA-ETEST = 4,0 ?G/ML (S). SAMPLE E: GROWTH ON VRE AGAR AFTER 48 H INCUBATION, VITEK 2 SUSCEPTIBLE (MIC 1) NO ETEST RESULT. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. BIOM?RIEUX INVESTIGATION WILL BE INITIATED.