MAUDE Adverse Event Report: HOLOGIC INC THINPREP 5000 PROCESSOR

Device Problems Failure to Obtain Sample (2533); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 01/01/2015

Event Type  No Answer Provided  

Event Description

A customer in (b)(6) reported their thinprep 5000 processor produced an error (se 6220 fe 026).The customer said the sample is being lost so she discontinued using the instrument.At this time the customer was unable to tell if the sample remaining in the vial was enough to reprocess the sample into a slide and would confirm this at a later time.A hologic a field service engineer (fse) was dispatched to the customer site.The fse confirmed and reproduced the error.The fse found that the most likely cause of the error was the filter rotator motor.The fse replaced parts and performed all required setups per the technical documentation, processed samples to ensure instrument is operations.Instrument operational.The customer reported to the fse on (b)(6) 2015 that they were able to reprocess the samples and create a slide without calling the pts back for some of the samples which were processed during the time of the error.However, for one of the samples it was not possible to get sufficient cells in order to give a diagnosis, therefore one pt must be recalled to give a new sample.Us: although the instrument produced an error code during this incident, this is a reportable event since a pt needed to be recalled for additional sample collection, which resulted in a delay in pt diagnosis.(b)(4): under the meddev guidelines this would not constitute a reportable incident as the instrument issued an appropriate fault/error code to alert the user, built in protection function as intended, by issuing the relevant warning.The error was verified by the dispatched engineer and resolved by technical intervention.

• Brand Name: THINPREP 5000 PROCESSOR
• Type of Device: THINPREP 5000 PROCESSOR
• Manufacturer (Section D): HOLOGIC INC; marlborough MA
• Manufacturer Contact: eva maxwell ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 4652659
• MDR Text Key: 5757025
• Report Number: 1222780-2015-00032
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• 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: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2015
• 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: 02/25/2015
• 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