MAUDE Adverse Event Report: HOLOGIC INC. THINPREP 3000 PROCESSOR

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

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/01/2014

Event Type  No Answer Provided  

Event Description

Customer reported their thinprep 3000 processor is having a waste sys failure and producing errors.The field service engineer confirmed, but was unable to reproduce the error.Processed samples to sample to confirm operation.Instrument operational.Us: this is a reportable event since the pt needed to be recalled for additional sample collection, which resulted in a delay in pt diagnosis.

• Brand Name: THINPREP 3000 PROCESSOR
• Type of Device: THINPREP 3000 PROCESSOR
• Manufacturer (Section D): HOLOGIC INC.; marlborough MA
• Manufacturer Contact: eva maxwell ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 4176272
• MDR Text Key: 18030963
• Report Number: 1222780-2014-00178
• 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
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2014

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2014
• Initial Date FDA Received: 10/14/2014
• 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