THINPREP IMAGING SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-05-25 for THINPREP IMAGING SYSTEM manufactured by Hologic, Inc.

Event Text Entries

[2788600] The issue reported via a 04/26/2012 medwatch form was abnormal cells missed by thinprep imager system (i. E. Abnormal cells not present in the 22 fields of view (fov) presented). The root causes derived from past investigations of reported abnormal cells not present in the 22 fovs fall mainly into two categories: rare event - an event in which the slide falls into the category where the cells in question would match our experience in the clinical trial as evidenced in table 8 of the thinprep imaging system operation summary and clinical info. Customer miss - determined by a hologic cystology applications specialist (cas) who in a blinded manner microscopically reviews the slide (s) in question at the laboratory. The cas identifies abnormal cells (trigger cells) in the original 22 fovs which should have prompted a full scan review. The root cause is determined to be the result of diagnostic misinterpretation and not related to the function/performance of the thinprep imager. Customer and instrument info were not included on medwatch form. There is no info on pt diagnosis, nor a delay in diagnosis. If further info becomes available, a separate complaint will be opened.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222780-2012-00121
MDR Report Key2593860
Report Source99
Date Received2012-05-25
Date of Report2012-04-26
Date of Event2011-02-18
Date Mfgr Received2012-04-26
Date Added to Maude2012-08-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Manufacturer ContactJOHN FARR
Manufacturer Street502 S ROSA RD
Manufacturer CityMADISON WI 53719
Manufacturer CountryUS
Manufacturer Postal53719
Manufacturer Phone6082362525
Manufacturer Street445 SIMARANO DR
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal Code01752
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTHINPREP IMAGING SYSTEM
Generic NameAUTOMATED MICROSCOPE FOR CYTOLOGY
Product CodeMNM
Date Received2012-05-25
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHOLOGIC, INC
Manufacturer AddressMARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2012-05-25

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