MAUDE Adverse Event Report: HOLOGIC INC THINPREP 300 PROCESSOR; THINPREP 3000 PROCESSOR

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/02/2014

Event Type  No Answer Provided  

Event Description

Customer reported that their instrument turned the thinprep vial upside down and all the contents spilled out.Customer shut down the thinprep 3000 process until it gets serviced.Customer will recollect spilled vial.Technical service could not replicate isolated incident.Technical service performed service and cleaned instrument and ran three trays of pt sample vials; instrument operational.This is a reportable event since the thinprep 3000 processor did not perform as intended and the pt needed to be recalled for additional sample collection, which resulted in a delay in pt diagnosis.

• Brand Name: THINPREP 300 PROCESSOR
• Type of Device: THINPREP 3000 PROCESSOR
• Manufacturer (Section D): HOLOGIC INC; marlborough MA
• Manufacturer Contact: eva maxwell ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 4132009
• MDR Text Key: 4797110
• Report Number: 1222780-2014-00167
• 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
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2014

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
• Initial Date Manufacturer Received: 09/02/2014
• Initial Date FDA Received: 09/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other