MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 5000 PROCESSOR

Device Problem Device Alarm System (1012)

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

Event Type  malfunction  

Manufacturer Narrative

Hologic field service engineer (fse) confirmed but unable to reproduce error.Found the following to be the most likely cause of the error.Instrument in need of the camera upgrade.Performed tsb 00882 2d camera upgrade.Performed all required setups per technical documentation.Processed samples to confirm operation.Instrument operational.(b)(4).

Event Description

A customer in (b)(6) reported an instance of their thinprep 5000 processor did not produce an error code.Customer requested hologic field service engineer (fse) to be dispatched to investigate.Fse was dispatched.The fse confirmed but unable to reproduce error.Found the following to be the most likely cause of the error.Instrument in need of the camera upgrade.Performed tsb 00882 2d camera upgrade and instrument operational.Even though there was no patient recall and delay in diagnosis the device did not function as intended.

• Brand Name: THINPREP 5000 PROCESSOR
• Type of Device: THINPREP 5000 PROCESSOR
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 5950401
• MDR Text Key: 55117393
• Report Number: 1222780-2016-00228
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2016
• 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