FDA.reportPublic FDA data

MAUDE MDR 8649352

MDR report key
8649352
Report number
1219913-2019-00098
Event key
0
Event type
3
Date of event
2019-05-06
Date received
2019-05-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LOUISE MCLAUGHLIN
Address
333 CONEY STREET EAST WALPOLE MA 02032 US
Phone
508-508-5086
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ATELLICA IM 1300 ALPHA FETOPROTEIN (AFP)AFP IMMUNOASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.LOKN/A1099544110938208R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-290

Event Narratives#

N

Patient 1

THE CAUSE FOR THE ELEVATED, NON-REPRODUCIBLE AFP RESULT ON THE ATELLICA IM 1300 IS UNKNOWN. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION TO INVESTIGATE THE ISSUE. THE INTERPRETATION OF RESULTS SECTION OF THE INSTRUCTIONS FOR USE STATES: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS."

D

Patient 1

CUSTOMER OBSERVED AN ELEVATED ALPHA FETOPROTEIN (AFP) RESULT ON THE ATELLICA IM 1300 THAT DID NOT MATCH THE CLINICAL PICTURE OR REPEAT RESULTS. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ATELLICA IM AFP RESULT.