FDA.reportPublic FDA data

MAUDE MDR 6089858

MDR report key
6089858
Report number
9610806-2016-00034
Event key
0
Event type
3
Date of event
2016-09-23
Date received
2016-11-09
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
JAMES MORGERA
Address
GLASGOW BUSINESS COMMUNITY PO BOX 6101 NEWARK DE 19714 US
Phone
302-302-3026
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1INNOVANCE D-DIMERINNOVANCE D-DIMERSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBHDAPSMN1044598045736N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-11-090

Event Narratives#

N

Patient 1

THE CAUSE OF THE DISCREPANT FALSELY DEPRESSED D-DIMER RESULT IS UNKNOWN. HOWEVER, ANALYSIS OF THE INSTRUMENT DATA REVEALED NO SYSTEMATIC FAILURES OR QC FAILURES. THE ISSUE IS AN ISOLATED OBSERVATION OF A PATIENT MEASUREMENT WITH A FALSELY LOW D-DIMER RESULT IN A SINGLE DETERMINATION WHICH IS DISCORDANT TO OTHER MEASUREMENTS. THE CAUSE OF THE ISSUE SEEMS TO BE RELATED TO THE AFFECTED 2ND SAMPLE. THIS SAMPLE IS DESCRIBED AS HAVING A HIGH COUNT OF FIBRIN MONOMERS. FIBRIN MONOMERS ARE AN INTERMEDIATES IN THE FIBRINOGEN ACTIVATION TO FIBRIN AND MAY CAUSE MICROCLOTS. SAMPLES WITH MICROCLOTS MAY CAUSE SAMPLE UNDER-ASPIRATION BY PIPETTOR CLOGGING AND BY THIS MAY DELIVER FALSE LOW RESULTS. MICROCLOTS CAN BE REMOVED BY CORRECT SAMPLE PREPARATION WITH CENTRIFUGATION, AND THEREFORE THE PRESENCE OF MICROCLOTS IS A PREANALYTICAL ISSUE WHICH IS UNDER THE USER'S RESPONSIBILITY. IN ADDITION, AS THE PATIENT HAS A KNOWN MALIGNANCY SUSPECTED FOR DIC/SEPSIS, THE RESULTS OF SUCH SAMPLES HAVE TO BE INTERPRETED WITH CAUTION AS THESE DISEASE STAGES ARE KNOWN TO POTENTIALLY INTERFERE WITH D-DIMER ANALYSIS AS INDICATED IN THE 'SUMMARY AND EXPLANATION' SECTION OF THE INSTRUCTIONS FOR USE. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

D

Patient 1

A DISCREPANT LOW D-DIMER RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE CS-5100 INSTRUMENT. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS RETESTED AND A HIGHER RESULT WAS OBTAINED AND REPORTED. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE DISCREPANT LOW D-DIMER RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCREPANT LOW D-DIMER RESULT.