MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 5000 PROCESSOR

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Type  No Answer Provided  

Event Description

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.

• Brand Name: THINPREP 5000 PROCESSOR
• Type of Device: THINPREP 5000 PROCESSOR
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: eva maxwell ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 5064519
• MDR Text Key: 25356091
• Report Number: 1222780-2015-00159
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: IO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other