THINPREP 5000 PROCESSOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-09 for THINPREP 5000 PROCESSOR manufactured by Hologic, Inc.

Event Text Entries

[25356091] A customer reported in (b)(6) that their thinprep 5000 processor autoloader etched a wrong vial id onto a slide. The customer processed the sample a second time and it processed correctly. Hologic's technical service engineer (tse) confirmed that the chain of custody was not affected as the error was caught by the customer. Hologic's technical service engineer (tse) suggested this may be caused by the vial lift and spin causing the vial to tilt during reading or poor quality labeling. A hologic's fields service engineer (fse) was dispatched to customer site to verify set vial lift and spin set ups. Fse confirmed but was unable to reproduce the error. Fse confirmed that no patient received an incorrect diagnosis as a result of this incident. Verified and adjusted instrument vial lift and spin. Processed samples to confirm operation, instrument operational. This is considered a reportable event since the thinprep 5000 processor autoloader did not perform as intended and this could potentially lead to a misdiagnosis or delay in diagnosis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222780-2015-00159
MDR Report Key5064519
Date Received2015-09-09
Date of Report2015-09-09
Date Mfgr Received2015-09-01
Date Added to Maude2015-09-09
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 ContactEVA MAXWELL
Manufacturer Street250 CAMPUS DRIVE
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTHINPREP 5000 PROCESSOR
Generic NameTHINPREP 5000 PROCESSOR
Product CodeMKQ
Date Received2015-09-09
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerHOLOGIC, INC
Manufacturer Address250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-09-09

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