MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 5000 PROCESSOR

Device Problem Device Operates Differently Than Expected (2913)

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 etched a wrong vial id onto 2 slides.Instrument operational, (b)(4) field service engineer (fse) dispatched.The instrument processed normally without any error presented to the operator.Fse noted 1d label on the vial, 2d label on the slide.The customer confirmed no patients needed to be recalled as a result of this incident as they were able to reprocess the slide with the correct label printed on the slide.Fse performed preventative maintenance per technical documentation.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: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 5615762
• MDR Text Key: 45097910
• Report Number: 1222780-2016-00105
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2016

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: 03/29/2016
• Initial Date FDA Received: 04/28/2016
• 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