MAUDE Adverse Event Report: HOLOGIC INC THINPREP 2000 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 instance of their thinprep 2000 processor producting errors (se 90, 43, 53 and 75).The instrument will suck up and then dump the sample fluid into the waste bottle but not make a slide.The field svc engineer confirmed; but was unable to reproduce the error.Replaced parts per technical documentation to resolve the error.Performed all required setups per technical documentation.Ran pneumatic test and processed blank 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 2000 PROCESSOR
• Type of Device: THINPREP 2000 PROCESSOR
• Manufacturer (Section D): HOLOGIC INC; marlborough MA
• Manufacturer Contact: eva maxwell ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 4176287
• MDR Text Key: 18094359
• Report Number: 1222780-2014-00177
• 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: 09/17/2014
• 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