MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 2000 PROCESSOR

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Venipuncture (2129)

Event Type  No Answer Provided  

Event Description

A customer in the us reported error codes se 45 nn on their thinprep 2000 processor.Hologic field service engineer (fse) instructed the customer to clean the cap seal ports and check the qto valve tubing.Customer called later to report multiple process cancelled evacuation failures and reported error codes se 45 and se 87.Customer cleaned the cap seal ports and rebooted the instrument and that 7 out of 20 have failed.Customer and hologic technical service agreed to put the dispatch on hold and send out a different lot of filters.Customer received replacement filters.Instrument fully operational.Jan 21, 2016: further investigation of this incident revealed patient(s) needed to be recalled for additional sample collection.Although the instrument produced an error code during this incident, this is a reportable event since the patient needed to be recalled for additional sample collection, which resulted in a delay in patient diagnosis.

• Brand Name: THINPREP 2000 PROCESSOR
• Type of Device: THINPREP 2000 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: 5384212
• MDR Text Key: 36962971
• Report Number: 1222780-2016-00018
• 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: 01/21/2016

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 01/21/2016
• 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