FDA.reportPublic FDA data

MAUDE MDR 8632776

MDR report key
8632776
Report number
1219913-2019-00081
Event key
0
Event type
3
Date of event
2019-04-16
Date received
2019-05-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. EIMAN SULIEMAN
Address
333 CONEY STREET E. WALPOLE MA 02032 US
Phone
508-508-5086
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (PTH) ASSAYPTH IMMUNOASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.CEWN/A1069915424274021R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-220

Event Narratives#

N

Patient 1

THE HIGH RESULTS WERE REPORTED ON APRIL 16TH AND APRIL 25TH. THE QUALITY CONTROL AND CALIBRATIONS WERE CHECKED AND WERE ACCEPTABLE. ALL THE RESULTS WERE FROM THE SAME REAGENT PACK. ALL THE REPEATED SAMPLES WERE USING THE SAME TUBE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AWAITING THE DETAILS OF THE FSE REPORT TO BE PROVIDED. SIEMENS HEALTHCARE DIAGNOSTICS IS AWAITING FURTHER INFORMATION. THE INTERPRETATION OF RESULTS OF THE INSTRUCTIONS FOR USE STATES: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS". THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE STATES: "INTERPRETATION OF INTACT PTH VALUES SHOULD ALWAYS TAKE INTO ACCOUNT SERUM CALCIUM RESULTS AND THE INTERRELATIONSHIP BETWEEN THESE 2 ELEMENTS IN VARIOUS DISORDERS INVOLVING PTH AND CALCIUM. IT IS RECOMMENDED THAT THE INTACT PTH RESULTS SHOULD ALWAYS BE INTERPRETED WITH CAUTION AND WITH CONSIDERATION OF THE OVERALL CLINICAL MANIFESTATIONS EVEN WHEN USED IN CONJUNCTION WITH CALCIUM VALUES..". MDR 1219913-2019-00094 WAS FILED FOR THE SAME EVENT.

D

Patient 1

DISCORDANT HIGH ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (PTH) RESULTS WERE OBTAINED FOR A "BIG AMOUNT" OF PATIENT SAMPLES. THE RESULTS WERE HIGHER THAN EXPECTED. THE SAMPLES WERE REPEATED, AND THE RESULTS WERE LOWER. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT PTH RESULT.