FDA.reportPublic FDA data

MAUDE MDR 319228

MDR report key
319228
Report number
1950204-2001-00001
Event key
0
Event type
3
Date of event
2000-08-09
Date received
2001-03-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
SANDRA PERREAND, DIRECTOR
Address
595 ANGLUM DRIVE HAZELWOOD MO 63042 US
Phone
314-314-3147
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VIDASIMMUNOFLUOROMETER EQUIPMENTBIOMERIEUX, INC.JZTVIDAS 30W2010NANYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-03-0101. R

Event Narratives#

D

Patient 1

LAB NOTED AFTER RUNNING CONTROLS THAT "RFV'S" FOR SECTION A2 (ONE OF 30 PUMP POSITIONS) WERE MUCH LOWER THAN THE ALLOWED RANGE. FIELD SVC WAS CALLED TO THE SITE AND REPLACED THE PUMP MOTOR ASSEMBLY AT WHICH TIME THE SECTION FUNCTIONED PROPERLY. LAB DETERMINED THAT THE PUMP AT POSITION A2 HAD NOT BEEN PUMPING PROPERLY FOR THE PERIOD OF TIME 8/7/00-8/10/00 DURING WHICH TIME VIDAS ASSAYS HAD BEEN RUN. UPON CORRECTION OF THE PROBLEM THE LAB PERFORMED REPEAT TESTING ON 2 HIV SAMPLES, BOTH OF WHICH GAVE THE SAME RESULTS AS ORIGINALLY REPORTED, 3 HEPATITIS B SAMPLES, TWO OF WHICH GAVE THE SAME RESULTS AS ORIGINALLY REPORTED AND ONE OF WHICH THAT WAS ORIGINALLY REPORTED AS