MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 2000 PROCESSOR

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Code Available (3191)

Event Type  No Answer Provided  

Event Description

A customer in the us reported their thin prep 2000 processor broke patient slides after creating the cell spot.There was not enough sample to reprocess so a patient needed to be recalled for additional sample collection.Hologic's field service engineer reported the incident was due to slide sensor flag colliding with sensor; adjusted flag to prevent collision; ran pneumatic and blank sample tests for verification; instrument operational.Us: this is a reportable event since the thin prep 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 (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: eva maxwell ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 5318152
• MDR Text Key: 34162671
• Report Number: 1222780-2015-00245
• 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: 12/22/2015

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: 12/01/2015
• Initial Date FDA Received: 12/22/2015
• 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