MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 5000 PROCESSOR

Device Problems Nonstandard Device (1420); Device Operates Differently Than Expected (2913)

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

Event Type  No Answer Provided  

Event Description

A customer in (b)(6) reported their thinprep 5000 processor with autoloader etched a wrong vial id onto a slide.The slide was first produced on (b)(6) 2016.The vial was rerun on (b)(6) 2016 and the correct number was etched onto the slide.The patient will need to be recalled as a result of this incident as there was no material available in the vial.No mismatch error between the slide and vial was presented to the operator.This is a reportable event since the thinprep 5000 processor did not perform as intended and the patient needed to be recalled for additional sample collection, which resulted in a delay in patient 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: 5564160
• MDR Text Key: 43019720
• Report Number: 1222780-2016-00083
• 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,Followup
• Report Date: 04/06/2016

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 04/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/08/2016
• 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