MAUDE Adverse Event Report: HOLOGIC INC. THINPREP 5000 PROCESSOR

Device Problems Device Reprocessing Problem (1091); Device Displays Incorrect Message (2591); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 01/01/2014

Event Type  No Answer Provided  

Event Description

Customer reported the thinprep 5000 processor produced an error (se 6006 sh 024), also broke some slides (before putting cells on them), and lost some sample (non-gyn, urocyte).The patient will be called back.The customer stopped the unit.Hologic field service engineer confirmed and reproduced error (se 6006 sh 024).Found the following to be the most likely cause of the error: dirty vacuum cups (cleaned).Replaced 3v battery cr 2032 (sbc).Ran all non-interactive motion and go no-go tests to verify instrument operation.Processed samples to confirm operation.Instrument operational.Spain: this is not classified as a reportable event since this is a technical issue.The instrument issued a warning/error code, which alerted the user.The dispatched engineer was able to confirm and reproduce that error and resolved the issue by technical/service intervention.

• Brand Name: THINPREP 5000 PROCESSOR
• Type of Device: THINPREP 5000 PROCESSOR
• Manufacturer (Section D): HOLOGIC INC.; marlborough MA
• Manufacturer Contact: eva maxwell ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 3897672
• MDR Text Key: 19408003
• Report Number: 1222780-2014-00094
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• 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: 05/19/2014

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: 05/19/2014
• Initial Date FDA Received: 06/10/2014
• 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