THINPREP IMAGING SYSTEM 70564-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-24 for THINPREP IMAGING SYSTEM 70564-001 manufactured by Hologic Inc..

Event Text Entries

[68356622] Serial number of the device not provided by the complainant, therefore the expiration date is not known. Serial of the disposable device not provided by the complainant, therefore the manufacture date is not known. Device history record (dhr) review was unable to be conducted for the disposable device as the identification number was not provided by the complainant. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[68356623] The customer reported observed abnormal cells that were not located in the 22 fovs selected by the imager. Hologic cytology application specialist (cas) reviewed slide ((b)(4)) as an unknown mixed with other slides. Case presented had no triggers in the 22 fovs (fields of view) to prompt an autoscan. Full review of slide during qc showed abnormal cells outside the fovs. Cas reviewed this case and discussed with lab supervisor. The agreed there were no changes seen in the 22 fov to prompt an autoscan. The slide showed a clean background with mature epithelium. One group/cluster of cells was found outside the 22 fovs that would prompt an auto scan. The case was diagnosed as low grade squamous intraepithelial lesion, (b)(6) 2016. The cas performed inspection and instrument operational.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222780-2017-00040
MDR Report Key6358037
Date Received2017-02-24
Date of Report2017-01-25
Date Mfgr Received2017-01-25
Date Added to Maude2017-02-24
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 Report0

Device Details

Brand NameTHINPREP IMAGING SYSTEM
Generic NameAUTOMATED MICROSCOPE FOR CYTOLOGY
Product CodeMNM
Date Received2017-02-24
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 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-02-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.