FDA.reportPublic FDA data

MAUDE MDR 580039

MDR report key
580039
Report number
1451914-2004-00004
Event key
0
Event type
3
Date received
2004-11-15
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 SPINDELL, D-09Y6, AP6C-2
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
1TESTPACK PLUS HCG-COMBORAPID PREGNANCY TESTABBOTT LABORATORIESJHJNA7B34-1616006M200K965116NYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-11-150

Event Narratives#

D

Patient 1

THE ACCOUNT GENERATED NEGATIVE TESTPACK PLUS HCG COMBO RESULTS USING URINE SPECIMENTS ON TWO PATIENTS FROM THE EMERGENCY ROOM WHO TESTED HCG QUANTITATIVE POSITIVE. THIS REPORT IS FOR PATIENT 1 OF 2 TOTAL PATIENTS. PATIENT 1 TESTED TESTPACK PLUS HCG COMBO NEGATIVE (URINE SPECIMEN), TESTPACK PLUS HCG COMBO WEAKLY POSITIVE (SERUM SPECIMEN), ICON II HCG COMBO POSITIVE AND HCG QUANTITATIVE METHOD = 66 (NO UNITS OF MEASUREMENT GIVEN). IT IS UNKNOWN IF THE URINE SPECIMEN FOR PATIENT 1 WAS RANDOM OR FIRST A MORNING SPECIMEN. NO ADDITIONAL PATIENT OR TESTING INFORMATION IS AVAILABLE. THE NEGATIVE TESTPACK PLUS HCG COMBO RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. A CORRECTED REPORT WAS SUBMITTED TO THE PHYSICIAN. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.