THINPREP IMAGING SYSTEM 70564-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2018-03-16 for THINPREP IMAGING SYSTEM 70564-001 manufactured by Hologic Inc..

Event Text Entries

[102626994] The customer reported observed abnormal cells that were not located in the 22 fovs selected by the imager. Cytology application specialist (cas) reviewed slide on the rsmp as an unknown mixed with other slides. Case presented had no triggers in the 22 fovs to prompt an autoscan. Full review of slide during qc showed abnormal cells outside the fovs. Cas reviewed this case and discussed with lab personnel. Cas agreed there were no changes seen in 22 fov to prompt an autoscan. Single sheet of lsil identified outside of fov. Please comment on the overall appearance of the slide: cellular, well prepared sample. Abnormal cells were discovered by the lab when: the case was discovered when doing 100% qc for new hire. Laboratory's interpretation of cells outside.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222780-2018-00047
MDR Report Key7345490
Report SourceCONSUMER,HEALTH PROFESSIONAL
Date Received2018-03-16
Date of Report2018-02-16
Date of Event2018-02-16
Date Mfgr Received2018-02-16
Date Added to Maude2018-03-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. SIDRA PIRACHA
Manufacturer Street250 CAMPUS DRIVE
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5082638884
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTHINPREP IMAGING SYSTEM
Generic NameAUTOMATED MICROSCOPE FOR CYTOLOGY
Product CodeMNM
Date Received2018-03-16
Model Number70564-001
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHOLOGIC INC.
Manufacturer Address250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-03-16

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