MAUDE Adverse Event Report: HOLOGIC INC. THINPREP 5000 PROCESSOR

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2015

Event Type  malfunction  

Event Description

A customer in (b)(6) initially reported their thinprep 5000 processor failed to read the barcode and requested service from hologic inc.Hologic dispatched a field service engineer (fse) to investigate the incident.The fse determined the instrument mismatched the slide and vial id.There was no delay in patient diagnosis, no misdiagnosis and the patient was not recalled as a result of this incident.The sample was reprocessed with the correct sample identifier etched on the slide.This is considered a reportable event since the thinprep 5000 processor did not perform as intended and this could potentially lead to a misdiagnosis.

• Brand Name: THINPREP 5000 PROCESSOR
• Manufacturer (Section D): HOLOGIC INC.; marlborough MA
• Manufacturer Contact: eva ,axwe;; ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 4873872
• MDR Text Key: 6059632
• Report Number: 1222780-2015-00116
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2015
• 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