FDA.reportPublic FDA data

MAUDE MDR 1341465

MDR report key
1341465
Report number
1415939-2008-00279
Event key
0
Event type
3
Date of event
2007-12-20
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 LABORATORIESGOLNA3B23-2055922M100Y Y

Patients#

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

Event Narratives#

D

Patient 1

THE CUSTOMER REPORTED FAILED AXSYM RUBELLA LGG CALIBRATION, WHERE ERROR CODE 1015 (MASTER CALIBRATION FAILURE, M-CAL 2, CURE DEVIATION) AND 1111 (CALIBRATION CHECK FAILURE, M-CAL 1, RESPONSE TOO LARGE) WERE GENERATED. THE CUSTOMER WAS SENT A NEW LOT OF RUBELLA CALIBRATORS AND A SUCCESSFUL CALIBRATION WAS ACHIEVED. THE CUSTOMER STATED THE SUSPECT CALIBRATORS HAD BEEN OPENED SINCE 2007 AND NEAR THE END OF THE BOTTLE, ALTHOUGH THE STORAGE CONDITONS FOR THE CALIBRATORS WERE FOLLOWED AT THE CUSTOMER SITE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED BY CUSTOMER.

N

Patient 1

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