FDA.reportPublic FDA data

MAUDE MDR 8233521

MDR report key
8233521
Report number
9610806-2019-00004
Event key
0
Event type
3
Date of event
2018-11-10
Date received
2019-01-10
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
CHRISTINA LAM
Address
511 BENEDICT AVE TARRYTOWN NY 10591 US
Phone
914-914-9145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BCS XP SYSTEMBCS XP SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBHGKPBCS XP SYSTEM10461894N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-100

Event Narratives#

N

Patient 1

THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER AND REPORTED THAT DISCORDANT, FALSELY LOW FIBRINOGEN RESULTS WERE OBTAINED ON TWO SAMPLES FROM THE SAME PATIENT ON A BCS XP SYSTEM USING THE FIB LOW 570 ASSAY PROTOCOL; ADDITIONALLY, THE CUSTOMER PROVIDED THE IMPRECISE PROTHROMBIN TIME (PT), PT % AND PT INTERNATIONAL NORMALIZED RATIO (INR) RESULTS OBTAINED ON THE SAMPLES. THE CUSTOMER REPORTED THAT THE ISSUE IS OBSERVED ON TWO BCS XP SYSTEMS AT THE LABORATORY, BUT DID NOT PROVIDE THE DATA TO SUPPORT THEIR REPORT. THE FIB570 ASSAY PROTOCOL IS USED AS A BACKUP FOR ICTERIC, HEMOLYZED OR LIPEMIC SAMPLES THAT COULD NOT BE PROCESSED WITH THE FIB ASSAY PROTOCOL. THE FIB LOW ASSAY PROTOCOL IS USED FOR SAMPLES WITH EXPECTED FIBRINOGEN CONCENTRATION BELOW THE NORMAL RANGE THAT CANNOT BE PROCESSED WITH FIB ASSAY PROTOCOL. SIEMENS IS INVESTIGATING THE ISSUE. MDR 9610806-2019-00004 WAS FILED FOR THE DISCORDANT RESULT(S) OBTAINED ON (B)(6) 2018 FOR SAMPLE ID (B)(6) AND MDR 9610806-2019-00005 WAS FILED FOR THE DISCORDANT RESULT(S) OBTAINED ON (B)(6) 2018 FOR SAMPLE ID (B)(6) FROM THE SAME PATIENT.

D

Patient 1

A DISCORDANT, FALSELY LOW FIBRINOGEN (FIB) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BCS XP SYSTEM, USING THE FIB LOW570 ASSAY PROTOCOL. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS PREVIOUSLY TESTED FOR FIB ON THE SAME SYSTEM USING THE FIB AND FIB570 ASSAY PROTOCOLS, AND COMPARED TO THE DISCORDANT RESULT, HIGHER RESULTS WERE OBTAINED USING THE FIB AND FIB570 ASSAY PROTOCOLS. THE RESULT OBTAINED USING THE FIB570 ASSAY PROTOCOL WAS CONSIDERED TO BE CORRECT AND WAS REPORTED TO THE PHYSICIAN(S). ADDITIONALLY, IMPRECISE PROTHROMBIN TIME (PT), PT %, AND PT INTERNATIONAL NORMALIZED RATIO (INR) RESULTS WERE OBTAINED ON THE SAMPLE USING THE DADE INNOVIN REAGENT AND SAME SYSTEM. THE CORRECT PT %, PT AND PT INR RESULTS FOR THIS PATIENT ARE UNKNOWN AND IT IS UNKNOWN IF ANY OF THE PT %, PT AND PT INR RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW FIBRINOGEN RESULT AND IMPRECISE PT %, PT AND PT INR RESULTS.