MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 3000 PROCESSOR

Device Problems Application Program Problem (2880); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  No Answer Provided  

Event Description

A customer in the us reported an instance of their thinprep 3000 processor producing error code se 16 24 15 00 (an operation failed during batch processing, pms pump im#0.The customer further stated that two patient samples were entirely drawn into the system forcing a recollection of samples.Hologic field service engineer (fse) dispatched to customer site.Found the spa waste fitting excluded to be the most likely cause of the error.Cleared the waste fitting exclusion to resolve the error.Ran pneumatic test and blank sample.Processed samples to confirm operation.Instrument operational.Although the instrument produced an error code during this incident, this is a reportable event since two patients needed to be recalled for additional sample collection, which resulted in a delay in patient diagnosis.

• Brand Name: THINPREP 3000 PROCESSOR
• Type of Device: THINPREP 3000 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: 5678926
• MDR Text Key: 46292361
• Report Number: 1222780-2016-00135
• 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: 05/24/2016

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: 05/03/2016
• Initial Date FDA Received: 05/25/2016
• 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