MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 5000 PROCESSOR

Device Problems Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913); Data Problem (3196)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Event Description

A customer in (b)(6) reported an incidence where their thinprep 5000 processor with autoloader etched a wrong vial id onto a slide.The customer explained that some alcohol/fixative spilled onto the vial which caused smudging on the barcode.The instrument did not present any error to the operator.Instrument operational; hologic field service engineer (fse) dispatched to customer site.Fse confirmed there was no delay in patient diagnosis as a result of this issue.Fse confirmed but unable to reproduce error.Found the following to be the most likely cause of the error, vial label smudged which could possibly cause the misread.Performed barcode reader alignment.Processed samples to confirm operation.Instrument operational.Although no patients needed to be recalled as a result of this incident this is a reportable event since the instrument did not perform as intended.

• 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: 5701019
• MDR Text Key: 47605232
• Report Number: 1222780-2016-00138
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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