FDA.reportPublic FDA data

MAUDE MDR 1341460

MDR report key
1341460
Report number
1415939-2008-00274
Event key
0
Event type
3
Date of event
2008-05-12
Date received
2009-03-12
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
KHAUDEJA BANO
Address
100 ABBOTT PARK ROAD ABBOTT PARK IL 60064 US
Phone
847-847-8479
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AXSYM RUBELLA LGG ANTIBODYMEIA FOR THE MEASUREMENT OF LGG ANTIBODY TO THE RUBELLA VIRUSABBOTT LABORATORIESGOLNA3B23-2055922M101Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-03-120

Event Narratives#

D

Patient 1

THE CUSTOMER STATED THAT THE AXSYM RUBELLA LGG REAGENT CALIBRATION FAILED WITH ERROR CODE 1048: CALIBRATION CHECK FAILURE, CALA/B RARTIO TOO HIGH, ON THE AXSYM ANALYZER. THE ABBOTT FIELD SERVICE ENGINEER (FSE) REPLACED THE SAMPLE CAROUSEL MOTOR, PERFORMED A ROBOTICS CALIBRATION, CLEANED THE MATRIX CELL CAROUSEL, PERFORMED A MEIA STATION VERIFICATION, A MEIA/FPIA OPTICS VERIFICATION, CHECK THE FLUIDS AND RECALIBRATED THE RUBELLA ASSAY WITHOUT RESOLUTION. THE FSE THEN RECALIBRATED WITH AN OLD LOT OF CALIBRATOR AND THE CALIBRATION PASSED. NO IMPACT TO PATIENT MANAGEMENT REPORTED.

N

Patient 1

(NO CONSEQUENCE OR IMPACT TO PATIENT). (CALIBRATION ERROR). (ERROR MESSAGE GIVEN) THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.