FDA.reportPublic FDA data

MAUDE MDR 4266434

MDR report key
4266434
Report number
2247117-2014-00082
Event key
0
Event type
3
Date of event
2014-11-06
Date received
2014-11-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
CASSANDRA KOCSIS
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
1IMMULITEIMMUNOASSAY ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS INC.JJQIMMULITE30001N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-11-200

Event Narratives#

D

Patient 1

PATIENT SAMPLES FROM ONE INTRAOPERATIVE PATIENT WERE DELAYED FROM TESTING WITH THE TURBO INTACT PARATHYROID HORMONE (TURBO IPTH) METHOD ON AN IMMULITE INSTRUMENT. THE PATIENT WAS IN SURGERY WHEN THE SAMPLES WERE RECEIVED BY THE LABORATORY. THE OPERATOR WAS UNABLE TO RUN THE SAMPLES ON THE IMMULITE INSTRUMENT, WHICH DID NOT HAVE POWER RUNNING TO IT. THE SAMPLES WERE THEN RUN ON AN IMMULITE 2000 INSTRUMENT, BUT THE AMOUNT OF TIME NEEDED TO OBTAIN RESULTS WAS LONGER. THE PATIENT WAS UNDER ANESTHESIA FOR AN ADDITIONAL HOUR DUE TO THE DELAY IN OBTAINING RESULTS. THE OPERATOR SPOKE TO THE PHYSICIAN AND VERIFIED THAT THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT.

N

Patient 1

A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT, THE CSE DISCOVERED THAT THE POWER SUPPLY WAS NOT OPERATIONAL. THE CSE INSTALLED A NEW POWER SUPPLY AND VERIFIED THE INSTRUMENT WAS OPERATIONAL. THE CAUSE OF THE DELAY IN OBTAINING IPTH RESULTS FOR AN INTRAOPERATIVE PATIENT WAS A MALFUNCTION OF THE POWER SUPPLY. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.