MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 5000 PROCESSOR

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  No Answer Provided  

Event Description

A customer in (b)(6) reported error 6209-cf-518 on their thinprep 5000 processor.It was reported the instrument turned a vial upside down spilling the entire sample and a patient needed to be recalled.The instrument was not operational and the customer requested a hologic field service engineer (fse) field to be dispatched.Hologic field service engineer (fse) was dispatched and found the following to be the most likely cause of the error.Z axis motor encoder.Replaced the following parts per technical documentation to resolve the error; z stage.Replaced the following parts as precautionary measure; gripper assy.Performed preventative maintenance per technical documentation.Performed all required setups per technical documentation.Processed samples to confirm operation.Instrument operational.Although the instrument produced an error code during this incident, this is a reportable event since the patient needed to be recalled for additional sample collection, which resulted in a delay in patient diagnosis.

• Brand Name: THINPREP 5000 PROCESSOR
• Type of Device: THINPREP 5000 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: 5247686
• MDR Text Key: 32101204
• Report Number: 1222780-2015-00216
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2015

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: No
• 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