MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 5000 PROCESSOR

Device Problems Display Difficult to Read (1181); Patient Data Problem (3197)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Event Description

A customer in (b)(6) reported their thinprep 5000 processor with autoloader etched a wrong vial id onto a slide.It was confirmed that all faulty slide id's were found and reprocessed, and there was no patient recall or delay in diagnosis as a result.(b)(4) field service engineer confirmed but unable to reproduce error.Found the following to be the most likely cause of the error.Possible label contamination in between barcode lines.Adjusted slightly the lift and spin.Uploaded logs for us inspection on the issue.Performed preventative maintenance per technical documentation.Processed samples to confirm operation.Instrument operational.Although no patients needed to be recalled as a result of this incident this is a reportable event since the instrument did not perform as intended.

• Brand Name: THINPREP 5000 PROCESSOR
• Type of Device: THINPREP 5000 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: 5488475
• MDR Text Key: 40306624
• Report Number: 1222780-2016-00049
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2016

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2016
• Initial Date FDA Received: 03/09/2016
• 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