MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 5000 PROCESSOR

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Hologic's field service engineer (fse) went to the facility and confirmed 6007/se026 and reproduced error.The fse found the most likely cause of the error slide rotator flag crashing with home sensor.The fse adjusted slide rotator to solve the issue.The fse also performed wizard for slide handoff to scara and wizard for carousel slide/vial/filter, as the instrument need.The fse ran all non-interactive tests to verify instrument operation.Processed samples to confirm operation (around 250).Instrument operational.Internal reference complaint: (b)(4).

Event Description

It was reported on (b)(6) 2016, the customer was running a batch overnight and the slides were left outside the fixative bath.The following day the customer saw a system error code 6007-se026 and also 6513-co547 on assy autoloader ready t5000.The patient needed to be recalled.Hologic's field service engineer (fse) called to attend site.

• 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: 6159239
• MDR Text Key: 62386221
• Report Number: 1222780-2016-00269
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: 950039/S26
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• 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: 11/11/2016
• 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