MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 5000 PROCESSOR

Device Problem Device Markings/Labelling Problem (2911)

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

Event Type  No Answer Provided  

Event Description

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.

• 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: 5194443
• MDR Text Key: 30127877
• Report Number: 1222780-2015-00192
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2015

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: 10/12/2015
• Initial Date FDA Received: 11/02/2015
• 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