THINPREP IMAGING SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-09-01 for THINPREP IMAGING SYSTEM manufactured by .

Event Text Entries

[24705701] Customer notified hologic of a slide with abnormal cells that were not located in the 22 fields of view (fov). Although the customer reported the event to hologic on (b)(6) 2015, the slide was from (b)(6) 2015. The customer discovered the slide during qc. This is a potential delay in diagnosis. Hologic's cytology application specialist (cas) reviewed the slide with a mix of other slides. The cas agreed that there were no abnormal cells in the 22 fov to prompt an autoscan (full review) of the slide. Customer does not want to submit the slide to hologic for further review.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222780-2015-00154
MDR Report Key5045860
Report SourceUSER FACILITY
Date Received2015-09-01
Date of Report2015-08-31
Date of Event2015-08-05
Date Mfgr Received2015-08-05
Date Added to Maude2015-09-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CHRISTINA MARABELLA
Manufacturer Street250 CAMPUS DRIVE
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5082638912
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTHINPREP IMAGING SYSTEM
Generic NameAUTOMATED MICROSCOPE FOR CYTOLOGY
Product CodeMNM
Date Received2015-09-01
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-09-01

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