FDA.reportPublic FDA data

MAUDE MDR 3252268

MDR report key
3252268
Report number
1628664-2013-00186
Event key
0
Event type
3
Date received
2013-07-29
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 C8000 SYSTEMABBOTT MANUFACTURING INCJIH01G06-01Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-07-290

Event Narratives#

D

Patient 1

THE CUSTOMER STATED AN ARCHITECT C8000 ANALYZER GENERATED A FALSELY ELEVATED LITHIUM RESULT FOR ONE PATIENT SAMPLE. THE ARCHITECT GENERATED AN INITIAL LITHIUM RESULT OF 2.4 AND A REPEAT LITHIUM RESULT OF 0.8 MMOL/L. A SECOND SAMPLE WAS DRAWN FROM THE PATIENT AND LITHIUM RESULTS OF 0.8, 1.5, 1.5, 0.83, 0.88, 0.78, AND 0.80 MMOL/L WERE GENERATED. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

N

Patient 1

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

N

Patient 1

FURTHER INVESTIGATION OF THE CUSTOMER'S ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE CUSTOMER REPLACED THE PROBE TUBING AND THE REAGENT PROBE TO RESOLVE THE ISSUE. TRACKING AND TRENDING DID NOT IDENTIFY ANY ADVERSE TREND FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.