FDA.reportPublic FDA data

MAUDE MDR 5247518

MDR report key
5247518
Report number
1222780-2015-00212
Event key
0
Event type
3
Date received
2015-11-24
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
EVA MAXWELL
Address
250 CAMPUS DRIVE MARLBOROUGH MA 01752 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THINPREP 5000 PROCESSORTHINPREP 5000 PROCESSORHOLOGIC, INCMKQN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-11-2401. O

Event Narratives#

D

Patient 1

A CUSTOMER IN (B)(6) REPORTED THEIR THINPREP 5000 PROCESSOR WITH AUTOLOADER ETCHED A WRONG VIAL ID ONTO A SLIDE. THE ERROR WAS CAUGHT BY THE CUSTOMER AT THE TIME AND NO PATIENTS WERE AFFECTED. HOLOGIC'S FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO CONFIRM THE ERROR. THIS IS CONSIDERED A REPORTABLE EVENT SINCE THE THINPREP 5000 PROCESSOR DID NOT PERFORM AS INTENDED.