FDA.reportPublic FDA data

MAUDE MDR 8280772

MDR report key
8280772
Report number
1823260-2019-90042
Event key
0
Event type
3
Date received
2019-01-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Contact
MICHAEL LESLIE
Address
9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US
Phone
317-317-3175
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ELECSYS PROLACTIN ASSAYRADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)ROCHE DIAGNOSTICSCFTPROLACTIN G2ASKU* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-280

Event Narratives#

N

Patient 1

THE INVESTIGATION STATED THE PATIENT WAS TAKING VERY HIGH DOSAGES OF BIOTIN. THE ISSUE OBSERVED IS CONSISTENT WITH INTERFERENCE CAUSED BY BIOTIN INTAKE. THE PATIENT SAMPLE WAS NOT AVAILABLE FOR FURTHER INVESTIGATION, THEREFORE, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE FOLLOW UP/CORRECTIVE ACTION WAS THAT THE SAMPLE WAS REQUESTED FOR INVESTIGATION BUT COULD NOT BE PROVIDED. NO DEVICES WERE RETURNED. THIS DEVICE IS NOT LABELED FOR SINGLE USE AND IS NOT REPROCESSED OR REUSED.

D

Patient 1

THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. LOW RESULTS WERE GENERATED BY THE COBAS 8000 E 602 MODULE. THE EVENT INVOLVED 1 PATIENT WITH LOW RESULTS FOR THE ELECSYS PROLACTIN ASSAY. THE PATIENT'S AGE WAS REQUESTED, BUT WAS NOT PROVIDED. THE PATIENT'S WEIGHT WAS REQUESTED, BUT WAS NOT PROVIDED. THE PATIENT'S GENDER WAS REQUESTED, BUT WAS NOT PROVIDED. THE PATIENT'S RACE WAS REQUESTED, BUT WAS NOT PROVIDED. THE PATIENT'S ETHNICITY WAS REQUESTED, BUT WAS NOT PROVIDED.