FDA.reportPublic FDA data

MAUDE MDR 789697

MDR report key
789697
Report number
2919069-2006-00098
Event key
0
Event type
3
Date received
2006-12-01
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
DR. DAVID BARCH, D-09Y6, AP6C-2
Address
100 ABBOTT PARK RD 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
1CELL-DYN 22 CALIBRATORCD22 CALIBRATORABBOTT DIAGNOSTICS DIVISION/CELLDYNKRZNA99120-013098NYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-12-010

Event Narratives#

N

Patient 1

ON-MARKET INSTABILITY FOR PLATELETS WITH CELL-DYN 22 CALIBRATOR LOTS 3098 AND 3099 IS BEING EXPERIENCED. THE CALIBRATOR COULD READ HIGHER BY AT LEAST 10% ON THE CELL-DYN RUBY AND AS MUCH AS 22% ON THE CELL-DYN 3200. IF THIS CALIBRATOR IS USED AND THE CALIBRATION FACTOR ON THE INSTRUMENT IS ADJUSTED, A NEGATIVE PLATELET SAMPLE BIAS COULD RESULT. AS A PRECAUTION, LOT 3100 WAS ALSO REMOVED FROM USE. INVESTIGATION INTO THE CAUSE OF THIS INSTABILITY IS IN PROGRESS. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

D

Patient 1

THE CUSTOMER STATES THAT PLT CONTROL VALUES ON CELL-DYN 3200 WERE HIGHER AFTER RECALIBRATING WITH A NEW LOT. THE CUSTOMER RECALIBRATED FOLLOWING THE CELL-DYN 22 CALIBRATOR PRODUCT RECALL. THERE IS NO REPORT OF SUSPECT PATIENT RESULTS.