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 2015-11-02 for THINPREP 5000 PROCESSOR manufactured by Hologic, Inc.

Event Text Entries

[30127877] A customer reported in (b)(6) that their thinprep 5000 processor etched a wrong vial id onto a slide which was processed sometime in (b)(6). The error was caught by the customer at the time and they reprocessed the sample with no issues. Hologic's field service engineer (fse) researched data logs but was unable to confirm the error. Hologic's fse scanned barcodes of more recent samples but was unable to reproduce the error. This is considered a reportable event since the thinprep 5000 processor did not perform as intended.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222780-2015-00192
MDR Report Key5194443
Date Received2015-11-02
Date of Report2015-10-30
Date Mfgr Received2015-10-12
Date Added to Maude2015-11-02
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 Received2015-11-02
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 2015-11-02

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