FDA.reportPublic FDA data

MAUDE MDR 6948214

MDR report key
6948214
Report number
2432235-2017-00554
Event key
0
Event type
3
Date of event
2017-09-08
Date received
2017-10-13
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MARGARITA KARAN
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
0ADVIA 2400ADVIA 2400SIEMENS HEALTHCARE DIAGNOSTICS INC.CFRADVIA 2400N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-10-130

Event Narratives#

N

Patient 1

THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT THE DISCORDANT GLUCOSE HEXOKINASE_3 RESULT. QUALITY CONTROL (QC) WAS WITHIN RANGE. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE SERVICE WAS PERFORMED OVER MULTIPLE VISITS. THE CSE PERFORMED ADJUSTMENT OF ASPIRATION PROBE. THE CSE OBSERVED REACTION CUVETTE WASHERS (WUD) NEEDED CLEANING. THE CSE PERFORMED CLEANING OF WUD PROBES. THE CSE REPLACED CLOT SENSOR. A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) REVIEWED THE INFORMATION PROVIDED AND CONCLUDED THE EVENT IS NOT DUE TO A REAGENT LOT OR METHOD ISSUE. THE DATA IS CONSISTENT WITH INSTRUMENT RELATED ISSUES WITH THE POTENTIAL CAUSE BEING THE CLOGGING OF WUD PROBES. IMPROPER WASHING OF THE REACTION TRAY (RRV) CUVETTES DUE TO THE CLOGGED DETERGENT AND ASPIRATION LINES ON THE WUD IS CONSISTENT WITH IMPRECISION ISSUES. THE CAUSE OF THE DISCORDANT GLUCOSE HEXOKINASE_3 RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO THE SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. MDR 2432235-2017-00550 WAS FILED FOR THE SAME EVENT. MDR 2432235-2017-00553 WAS FILED FOR THE SAME EVENT.

D

Patient 1

DISCORDANT, GLUCOSE HEXOKINASE_3 RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN ADVIA 2400 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT GLUCOSE HEXOKINASE_3 RESULTS.