FDA.reportPublic FDA data

MAUDE MDR 2955237

MDR report key
2955237
Report number
1415939-2013-00038
Event key
0
Event type
3
Date of event
2013-01-23
Date received
2013-02-11
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
NOEMI ROMERO-KONDOS, RN BSN
Address
100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 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
1ARCHITECT CYCLOSPORINEABBOTT LABORATORIESMKW01L75-2518265M500Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-02-110

Event Narratives#

D

Patient 1

THE CUSTOMER OBSERVED DISCREPANT CYCLOSPORINE RESULTS WHILE USING THE ARCHITECT CYCLOSPORINE ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS (NG/ML): SID (B)(6): INITIAL 245.4, RETEST 113.5; COMPARED TO MASS SPEC RESULTS: 60, 70 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

N

Patient 1

(B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

N

Patient 1

FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. IT WAS NOTED THAT SAMPLE HANDLING ISSUES WERE IDENTIFIED AT THE CUSTOMER SITE. AN ACCURACY TESTING PROTOCOL WAS EXECUTED USING LOT 18265M500; TESTING MET THE ACCEPTANCE CRITERIA AND DETERMINED THE REAGENT IS PERFORMING ACCEPTABLY. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY AND NO MALFUNCTION OF THE ARCHITECT CYCLOSPORINE REAGENT LIST NUMBER 01L75, LOT NUMBER 18265M500, WAS IDENTIFIED.