MAUDE Adverse Event Report: HOLOGIC INC. THINPREP 5000 PROCESSOR

Device Problems Display Difficult to Read (1181); Device Markings/Labelling Problem (2911)

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

Event Date 01/01/2015

Event Type  No Answer Provided  

Event Description

A customer in (b)(6) reported their thinprep 5000 processor autoloader printed a different id code number onto a slide than what was on the sample vial.The customer operated the thinprep 5000 processor autoloader again with the same vial and the id was correctly printed onto the slide.The customer reported that this was the first time they had seen this issue.The customer investigated several times in their laboratory and found the vial was correctly printed on the slide.The reported issue has not been confirmed by either the customer, or by hologic (b)(4).This is considered a reportable event since the thinprep 5000 processor may not have performed as intended and this could potentially lead to a misdiagnosis or delay in diagnosis.

• Brand Name: THINPREP 5000 PROCESSOR
• Type of Device: THINPREP 5000 PROCESSOR
• Manufacturer (Section D): HOLOGIC INC.; marlborough MA
• Manufacturer Contact: eva maxwell ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 5000668
• MDR Text Key: 24699543
• Report Number: 1222780-2015-00141
• 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
• Report Date: 08/11/2015

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: Not provided
• Initial Date FDA Received: 08/11/2015
• 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