FDA.reportPublic FDA data

MAUDE MDR 3187970

MDR report key
3187970
Report number
1222780-2013-00125
Event key
0
Event type
3
Date of event
2013-05-21
Date received
2013-06-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
RANDALL COVILL, MGR
Address
250 CAMPUS DRIVE MARLBOROUGH MA 01752 US
Phone
508-508-5082
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THINPREP IMAGING SYSTEMAUTOMATED MICROSCOPE FOR CYTOLOGYHOLOGIC INCMNM* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-06-2001. L

Event Narratives#

D

Patient 1

LAB PERSONNEL REPORTED A CASE WITH OBSERVED ABNORMAL CELLS THAT WERE NOT LOCATED IN THE 22 FIELDS OF VIEW (FOV) SELECTED BY THE IMAGER. CYTOLOGY APPLICATION SPECIALIST (CAS) REVIEWED SLIDES ON THE REVIEW SCOPE AS AN UNKNOWN MIXED WITH OTHER SLIDES. TWO CASES PRESENTED HAD NO TRIGGERS IN THE 22 FOBS TO PROMPT AN AUTOSCAN. FULL REVIEW OF SLIDE DURING QC SHOWED ABNORMAL CELLS OUTSIDE THE FOVS. CAS REVIEWED THIS CASE AND DISCUSSED WITH LAP PERSONNEL. CAS AGREED THERE WERE NO CHANGES SEEN IN 22 FOV TO PROMPT AN AUTOSCAN. PLEASE COMMENT ON NUMBER OF ABNORMAL CELLS PRESENT: RARE. PLEASE COMMENT ON THE OVERALL APPEARANCE OF THE SLIDE: (B)(6): THE BACKGROUND OF THE SLIDE WAS CYTOLYSIS THERE WAS ONE GROUP OF LSIL; (B)(6): THE BACKGROUND WAS CLEAN WITH SUPERFICIAL AND INTERMEDIATE CELLS. THERE WAS ONE LARGE KERATINIZED CELL WITH A LARGE ABNORMAL NUCLEUS. THE NUCLEUS LOOKED A LITTLE DEGENERATE. CUSTOMER DID NOT REQUEST SLIDE TO BE REVIEWED AT CORPORATE. CUSTOMER WILL CONTINUE TO HOLD QUESTIONABLE CASES FOR CAS REVIEW. CUSTOMER DID NOT REQUIRE FOLLOW UP FROM CUSTOMER SUPPORT SERVICES.