FDA.reportPublic FDA data

MAUDE MDR 5407262

MDR report key
5407262
Report number
1222780-2016-00023
Event key
0
Event type
3
Date received
2016-02-03
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
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, INCMKQR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-02-0301. O

Event Narratives#

D

Patient 1

A CUSTOMER IN (B)(6) REPORTED ERROR 6204-VE-026 ON THEIR THINPREP 5000 PROCESSOR WITH AUTOLOADER. IT WAS REPORTED THE INSTRUMENT SPILLED THE ENTIRE SAMPLE AND A PATIENT NEEDED TO BE RECALLED. THE INSTRUMENT IS OPERATIONAL BUT THE CUSTOMER REQUESTED A HOLOGIC FIELD SERVICE ENGINEER (FSE) FIELD TO BE DISPATCHED AS THIS IS THE SECOND TIME THIS HAPPENED THIS MONTH ((B)(4)). HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND CONFIRMED BUT UNABLE TO REPRODUCE THE ERROR. REPLACED PARTS PER TECHNICAL DOCUMENTATION TO RESOLVE THE ERROR. PERFORMED PREVENTATIVE MAINTENANCE PER TECHNICAL DOCUMENTATION. PROCESSED SAMPLES TO CONFIRM OPERATION. INSTRUMENT OPERATIONAL. ALTHOUGH THE INSTRUMENT PRODUCED AN ERROR CODE DURING THIS INCIDENT, THIS IS A REPORTABLE EVENT SINCE THE PATIENT NEEDED TO BE RECALLED FOR ADDITIONAL SAMPLE COLLECTION, WHICH RESULTED IN A DELAY IN PATIENT DIAGNOSIS.