FDA.reportPublic FDA data

MAUDE MDR 719653

MDR report key
719653
Report number
3002769706-2005-00027
Event key
0
Event type
3
Date of event
2005-06-22
Date received
2005-08-01
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
NANCY OLSCAMP, SR. SPECIALIST
Address
100 RODOLPHE ST. DURHAM NC 27712 US
Phone
919-919-9196
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BACT ALERT 3D INSTRUMENTMICROBIAL GROWTH MONITORBIOMERIEUX, INC.JTANA43002-901NANY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-08-0101. O

Event Narratives#

D

Patient 1

THE BACT 3D INSTRUMENT IS USED WITH BLOOD CULTURE BOTTLES TO DETECT MICROBIAL GROWTH. THE COMPLAINT WAS REGARDING A CUSTOMER SUSPECTING POSSIBLE GALSE NEGATIVES WHEN USING BACT/ALERT PF BOTTLES. FURTHER ANALYSIS OF 37 BOTTLES INDICATED 3 POSSIBLE POSITIVE RESULTS AT THE END OF THE RECOMMENDED INCUBATION PERIOD FOR THE SAMPLES. THE RESULTS WERE HOWEVER, CONSIDERED TO BE INCONCLUSIVE. THE TWO PATIENTS INVOLVED HAD A HISTORY OF REPORTING CONSISTENTLY NEGATIVE BLOOD CULTURES. TREATMENT ON THE TWO PTS WAS BASED ON THE INITIAL NEGATIVE RESULTS AND NEITHER PT RECEIVED ANTIFUNGAL TREATMENT. NO ADVERSE EVENTS HAVE BEEN REPORTED SINCE THIS TIME.