FDA.reportPublic FDA data

MAUDE MDR 7704806

MDR report key
7704806
Report number
1823260-2018-02405
Event key
0
Event type
3
Date of event
2018-05-14
Date received
2018-07-19
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
NA MICHAEL LESLIE
Address
9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US
Phone
317-317-3175
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1D-DIMERFIBRIN SPLIT PRODUCTSROCHE DIAGNOSTICSGHHNA04912551190278482R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-07-190

Event Narratives#

N

Patient 1

THIS EVENT OCCURRED IN (B)(6).

D

Patient 1

THE CUSTOMER RECEIVED QUESTIONABLE HIGH D-DI TINA-QUANT D-DIMER GEN 2 RESULTS FOR ONE PATIENT FROM THE COBAS 4000 C (311) SYSTEM. THE SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. THE INITIAL RESULT WAS 1080 NG/ML AND WAS REPORTED OUTSIDE OF THE LABORATORY. AS THIS WAS UNEXPECTEDLY HIGH, THE PATIENT WENT FOR RETESTING IN ANOTHER LABORATORY. THE TEST WAS PERFORMED ON STA COMPACT MAX INSTRUMENT AND THE RESULT WAS