MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 2000 PROCESSOR

Device Problems Complete Blockage (1094); Reflux within Device (1522)

Patient Problem No Patient Involvement (2645)

Event Type  No Answer Provided  

Event Description

A customer in (b)(6) reported their thin prep 2000 processor is sucking fluid out of the vials and not creating a cell spot on the slide.Hologic field service engineer (fse) dispatched to customer site.Ts confirmed no patients needed to be recalled as a result of this incident.Fse confirmed and reproduced error.Found the following to be the most likely cause of the error: evacuation line clogged (cleaned all line and fittings) replaced the following parts as precautionary measure: waste tubing.Ran pneumatic test and blank sample.Processed samples to confirm operation.Instrument operational.Although no patients needed to be recalled as a result of this incident this is a reportable event since the instrument did not perform as intended.

• 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: 5382537
• MDR Text Key: 36587534
• Report Number: 1222780-2016-00017
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2015
• 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