FDA.reportPublic FDA data

MAUDE MDR 8286065

MDR report key
8286065
Report number
1219913-2019-00009
Event key
0
Event type
3
Date of event
2019-01-08
Date received
2019-01-29
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
MS. EIMAN SULIEMAN
Address
333 CONEY STREET E. 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 ALPHA FETOPROTEIN (AFP)AFP IMMUNOASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.LOJN/A10995441204R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-290

Event Narratives#

N

Patient 1

A FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. NO ISSUES WERE IDENTIFIED. THE QUALITY CONTROL RESULTS WERE WITHIN SPECIFICATIONS. THE CAUSE FOR THE DISCORDANT AFP RESULTS IS UNKNOWN. POSSIBLE SAMPLE HANDLING. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. THE IFU STATES IN THE INTERPRETATION OF RESULTS SECTION: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS."

D

Patient 1

A FALSE HIGH ATELLICA IM ALPHA FETOPROTEIN (AFP) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED ON THE ADVIA CENTAUR AND THE RESULT WAS LOWER. THE PATIENT SAMPLE WAS REPEATED ON THE ATELLICA IM AND THE RESULTS WERE LOWER. A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AFP RESULTS.