MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 5000 PROCESSOR

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

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

Event Type  No Answer Provided  

Manufacturer Narrative

(b)(4).

Event Description

A customer in (b)(6) reported their thinprep 5000 processor with autoloader printed the wrong number on the vial.All other vials in the same processing tray were checked and the numbers were found to be correct, no extra bar codes were found.The vial number 1620013697 was reloaded as a single sample on the t5 and was reprocessed correctly.No patient recall needed.Hologic's field service engineer (fse) confirmed but unable to reproduce the error.The barcode reader with linear base scanner is the most likely cause of the barcode misread.Performed the 2d barcode reader upgrade, processed samples to confirm operation.Instrument operational.

• 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 pirachal ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 5922493
• MDR Text Key: 54442117
• Report Number: 1222780-2016-00222
• 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: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2016
• 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