MAUDE Adverse Event Report: THINPREP 2000 PROCESSOR

Device Problem Kinked (1339)

Patient Problem No Code Available (3191)

Event Type  No Answer Provided  

Manufacturer Narrative

The device is not being returned.

Event Description

A customer in portugal reported that their thinprep 2000 processor was not operational and requested service.The customer indicated there was no error code but that the instrument stopped processing samples.Hologic field service engineer (fse) was dispatched.Hologic's fse confirmed and reproduced the error and found the following to be the most likely cause of the error; crinkled tubing.Hologic's fse replaced the following parts as precautionary measure: e-chain + hpt sensor.Performed preventative maintenance per technical documentation.Ran pneumatic test and blank sample.Processed samples to confirm operation.Instrument operational.Additional information received from the fse confirmed the customer was able to recover most samples, however one patient needed to be recalled as a result of this incident.This is a reportable event since the thinprep 2000 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 2000 PROCESSOR
• Type of Device: THINPREP 2000 PROCESSOR
• Manufacturer Contact: eva maxwell ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 5221277
• MDR Text Key: 31207157
• Report Number: 1222780-2015-00200
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2015

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: Other Health Care Professional
• Initial Date Manufacturer Received: 10/22/2015
• Initial Date FDA Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other