FDA.reportPublic FDA data

MAUDE MDR 7162122

MDR report key
7162122
Report number
2247117-2018-00001
Event key
0
Event type
3
Date of event
2017-12-07
Date received
2018-01-03
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
MS. 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
1IMMULITE 2000IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS INC.JJQIMMULITE 2000N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-01-030

Event Narratives#

N

Patient 1

THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CCC SPECIALIST REVIEWED ADJUSTMENT GUIDELINES WITH THE CUSTOMER. THE CUSTOMER READJUSTED THE KIT LOT WITH A FRESH SET OF ADJUSTORS AND ADJUSTMENT SLOPE RETURNED TO HISTORICAL PERFORMANCE AND QUALITY CONTROL (QC) RESULTED IN RANGE. THE CAUSE FOR THE CUSTOMER TO REPORT PATIENT RESULTS WHILE QC WAS OUT OF RANGE IS DUE TO USER ERROR. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

D

Patient 1

DISCORDANT THYROID STIMULATING HORMONE (TSH) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN IMMULITE 2000 INSTRUMENT WHEN QUALITY CONTROL (QC) LEVEL 1 WAS OUT OF RANGE LOW. AND THIS IS DOCUMENTED IN THE DATA LOGS. THESE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE IMMULITE 2000 INSTRUMENT. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT TSH RESULTS.