FDA.reportPublic FDA data

MAUDE MDR 7207695

MDR report key
7207695
Report number
9610806-2018-00013
Event key
0
Event type
3
Date of event
2017-12-26
Date received
2018-01-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LORIANN RUSSO
Address
511 BENEDICT AVENUE TARRYTOWN NY 10591 US
Phone
914-914-9145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DADE ACTIN FS ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENTDADE ACTIN FS ACTIVATED PTT REAGENTSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBHGGW10445710538525N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-01-190

Event Narratives#

N

Patient 1

SIEMENS HEALTHCARE DIAGNOSTICS INC. IS INVESTIGATING THE CAUSE OF THE DISCORDANT HIGH ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT), PROTHROMBIN TIME (PT), INTERNATIONAL NORMALIZED RATIO (INR), AND DERIVED FIBRINOGEN (DER FIB) PATIENT RESULTS ON ONE (1) PATIENT SAMPLE THAT WERE GENERATED ON A SYSMEX CS-5100 ANALYZER (SN (B)(4)). MDR 9610806-2018-00014 WAS FILED FOR THE SAME EVENT.

D

Patient 1

DISCORDANT HIGH ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT), PROTHROMBIN TIME (PT), INTERNATIONAL NORMALIZED RATIO (INR), AND DERIVED FIBRINOGEN (DER FIB) PATIENT RESULTS ON ONE (1) PATIENT SAMPLE WERE GENERATED ON A SYSMEX CS-5100 ANALYZER (SN (B)(4)). THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN AS THEY DID NOT MEET THE CLINICAL HISTORY OF THE PATIENT. THE SAME PATIENT SAMPLE WAS REPEATED ON A DIFFERENT SYSMEX CS-5100 (SN (B)(4)) AND LOWER APTT, PT, INR, AND DER FIB PATIENT RESULTS WERE GENERATED. THESE RESULTS WERE REPORTED TO THE PHYSICIAN. ALL RESULTS WERE RUN ON THE SAME DAY ((B)(6) 2017) ON THE SAME PATIENT SAMPLE. THE PT /INR /DER FIB PATIENT RESULTS (INITIAL AND REPEAT) WERE GENERATED USING THROMBOREL S REAGENT AND APTT PATIENT RESULTS (INITIAL AND REPEAT) WERE GENERATED USING THE DADE ACTIN FS ACTIVATED PARTIAL THROMBOPLASTIN TIME (PTT) REAGENT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HIGH APTT, PT, INR, AND DER FIB PATIENT RESULTS.