MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 3000 PROCESSOR

Device Problems Complete Blockage (1094); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

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

Event Type  No Answer Provided  

Event Description

A customer in the us reported an instance of their thinprep 3000 processor having a fixative clogged which was resolved by cleaning nozzle with warm water.However, now reports the machine is sucking up all the sample in the vial and not able to make a slide.According to caller, no error code or message is present.System is not usable and taken offline.Hologic field service engineer (fse) dispatched to the customers site.Fse found evacuation valve to be cause of problem.Replaced qto valve as a precaution.Replaced fixative air brush and lee valve for slow flow.All replacements and verifications performed per technical documentation.Ran pneumatic test and blank sample to verify instrument operational.This is a reportable event since the thinprep 3000 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 3000 PROCESSOR
• Type of Device: THINPREP 3000 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: 5732118
• MDR Text Key: 47607863
• Report Number: 1222780-2016-00146
• 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: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• 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: 06/02/2016
• 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