FDA.reportPublic FDA data

MAUDE MDR 6861360

MDR report key
6861360
Report number
9610806-2017-00099
Event key
0
Event type
3
Date of event
2017-08-14
Date received
2017-09-13
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
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
1INNOVANCE? D-DIMERINNOVANCE? D-DIMERSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBHDAPINNOVANCE? D-DIMER1044598247386N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-09-130

Event Narratives#

N

Patient 1

A SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) CUSTOMER SERVICE ENGINEER (CSE) AND A TECHNICAL APPLICATION SPECIALIST (TAS) WERE DISPATCHED TO THE CUSTOMER'S SITE TO DETERMINE THE CAUSE OF THE POTENTIAL FALSE NEGATIVE D-DIMER RESULTS ON THE BCS XP SYSTEM. DURING THE INVESTIGATION, THE CSE OBSERVED THAT THE CALIBRATION CURVE, USED TO RUN PATIENT SAMPLES, ON THE BCS XP SYSTEM WAS UNACCEPTABLE. THE CSE CHANGED THE REAGENT LOT, CALIBRATED THE SYSTEM, REPLACED THE SAMPLE PROBES, AND FLUSHED THE BCS XP SYSTEM OF THE BARBICIDE DISINFECTANT CLEANER. THE PRECISION TEST, VALIDATION AND LAMP WERE WITHIN SPECIFICATIONS. THE INTERNAL QC RECOVERED WITHIN EXPECTED RANGES. UPON FURTHER INVESTIGATION, SIEMENS DETERMINED THAT THE CUSTOMER IS USING RECYCLED CUVETTE ROTORS. BASED ON THE BCS? XP SYSTEM'S INSTRUCTION MANUAL, CUVETTES ARE ONLY INTENDED FOR SINGLE USE. IF USED MORE THAN ONCE, THIS COULD RESULT IN INACCURATE MEASUREMENT RESULTS. THE USE OF RECYCLED CUVETTE ROTORS IS A USER ERROR AND POTENTIALLY CONTRIBUTED TO THE DISCORDANT RESULT. SIEMENS HAS INSTRUCTED THE CUSTOMER TO DISCONTINUE THE USE OF RECYCLED CUVETTE ROTORS. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS SYSTEM IS REQUIRED. MDR 9610806-2017-00098, MDR 9610806-2017-00100, MDR 9610806-2017-00101, AND MDR 9610806-2017-00102 WERE FILED FOR THE SAME EVENT.

D

Patient 1

MULTIPLE POTENTIAL FALSE NEGATIVE D-DIMER RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES USING AN UNACCEPTABLE CALIBRATION CURVE ON THE BCS XP SYSTEM. THE D-DIMER RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. THE AFFECTED PATIENT SAMPLES WERE NOT RERUN AND CORRECTED REPORTS WERE NOT PROVIDED TO THE PHYSICIAN(S). THE CORRECT RESULTS FOR THE AFFECTED PATIENTS ARE UNKNOWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POTENTIAL FALSE NEGATIVE D-DIMER RESULTS OBTAINED ON THE PATIENT SAMPLES ON THE BCS XP SYSTEM.