FDA.reportPublic FDA data

MAUDE MDR 6441987

MDR report key
6441987
Report number
1950204-2017-00100
Event key
0
Event type
3
Date received
2017-03-29
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
1VITEK? 2 GN TEST KITVITEK? 2 GN TEST KITBIOMERIEUX, INCJTO21341241396710R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-03-290

Event Narratives#

D

Patient 1

A CUSTOMER IN (B)(6) NOTIFIED BIOM?RIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK? 2 GN TEST KIT (REFERENCE 21341) RELATED TO MISIDENTIFICATION OF AN ORGANISM. THE CUSTOMER REPORTED RESULTS FROM A URINE ISOLATE. THE ORGANISM GREW FROM A PURE URINE CULTURE AT 35 DEGREES IN NON-CO2 INCUBATOR. IT WAS A NON-LACTOSE FERMENTING ORGANISM AND THE VITEK? ID CARD IDENTIFIED THE ORGANISM AS SALMONELLA BOTH TIMES. THE SEROLOGY FOR SALMONELLA WAS NEGATIVE AND THE CUSTOMER SENT THE ORGANISM TO THEIR REFERENCE LABORATORY WHICH IDENTIFIED THE ORGANISM AS E. COLI. THE "MALDIT" OF IDENTIFICATION WAS ALSO E. COLI AND SIMPLE TESTS SHOWED THE FOLLOWING REACTIONS: INDOLE +/-, LACTOSE NEGATIVE, TSI= A/A NO H2S. 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. THERE WAS A DELAY IN THE FINAL REPORT UNTIL CONFIRMATION IDENTIFICATION WAS RECEIVED FROM BCCDC. AN INTERNAL BIOM?RIEUX INVESTIGATION WILL BE INITIATED.