FDA.reportPublic FDA data

MAUDE MDR 4111371

MDR report key
4111371
Report number
2432235-2014-00551
Event key
0
Event type
3
Date of event
2014-07-03
Date received
2014-09-23
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
MS. ELIZABETH BEATO
Address
511 BENEDICT AVENUE 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/IMMULITE 1000 CORTISOLIMMULITE/IMMULITE 1000 CORTISOLSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITEDCGRIMMULITE/IMMULITE 1000 CORTISOLLKCO382N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-09-230

Event Narratives#

D

Patient 1

THE CUSTOMER HAS OBSERVED HIGH BIAS RESULTS ON TWO LEVELS FOR BIORAD QUALITY CONTROL SAMPLES WHEN USING THE CORTISOL ASSAY REAGENT LOT 382 ON AN IMMULITE 1000 SYSTEM. THE BIAS WAS ALSO OBSERVED BY THE CUSTOMER FOR REAGENT LOTS 378 AND 379. THE CUSTOMER DID NOT REPORT ANY PATIENT SAMPLE DATA. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH BIAS OBSERVED ON THE BIORAD QUALITY CONTROL SAMPLES.

N

Patient 1

SIEMENS HAS CONFIRMED THAT IMMULITE/IMMULITE 1000 CORTISOL KIT LOTS 381, 382, AND 383 DEMONSTRATE A POSITIVE BIAS WITH PATIENT SAMPLES IN THE RANGE OF APPROXIMATELY 13% TO 40%. THE POSITIVE BIAS WAS ALSO OBSERVED IN QUALITY CONTROL MATERIALS AND MAY RESULT IN VALUES OUTSIDE THE ESTABLISHED RANGES. THE ISSUE HAS BEEN RESOLVED WITH IMMULITE/IMMULITE 1000 CORTISOL KIT LOTS (B)(4) AND ABOVE. AN URGENT MEDICAL DEVICE RECALL UMDR2014-09-19 WAS SENT TO US CUSTOMERS AND AN URGENT FIELD SAFETY NOTICE (UFSN) 1111, WAS SENT TO OUS CUSTOMERS IN SEPTEMBER OF 2014. THE UMDR AND UFSN STATE THAT CUSTOMERS ARE REQUESTED TO DISCONTINUE USE OF AND DISCARD THE IMMULITE/IMMULITE 1000 CORTISOL KITS LISTED, AND TO REVIEW THE UMDR/UFSN WITH THEIR MEDICAL DIRECTOR.