MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 5000 PROCESSOR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

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.The error was caught by the customer at the time and no patients were affected.Hologic's field service engineer (fse) was unable to confirm the error.This is considered a reportable event since the thinprep 5000 processor did not perform as intended.

Manufacturer Narrative

After reassessing this incident it has been determined that the customer was using an unsupported label barcode symbology; therefore this is not a reportable event in the us as it was previously reported (1222780-2015-00214).As per the current operator manual (man-01783-001 rev 008) the only supported symbologies are code 128, interleaved 2 of 5, code 39 and code 93; the customer was using codabar symbology.

• 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: 5246561
• MDR Text Key: 32100827
• Report Number: 1222780-2015-00214
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2015
• 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