FDA.reportPublic FDA data

MAUDE MDR 1341458

MDR report key
1341458
Report number
1415939-2008-00270
Event key
0
Event type
3
Date of event
2008-05-08
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 LABORATORIESGOLNA3B23-2057577M201Y 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 GENERATING ERROR CODE 1010: MASTER CALIBRATION FAILURE, M-CAL 2 DEVIATION TOO LARGE, ON THE AXSYM ANALYZER. SYSTEM MAINTENANCE IS PERFORMED REGULARLY AND NO OTHER ASSAYS ARE EFFECTED. NO IMPACT TO PATIENT MANAGEMENT REPORTED.

N

Patient 1

THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.