MAUDE Adverse Event Report: HOLOGIC INC THINPREP 5000 PROCESSOR

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 01/01/2014

Event Type  No Answer Provided  

Event Description

A customer in (b)(6) reported their thinprep 5000 processor lost a sample slide and produced an error ((b)(4)).This happened only once but the customer was concerned it may happen again so they called hologic for service.The field service engineer confirmed, but was unable to reproduce the error.The field service engineer conducted various testing and processed samples to ensure instrument is operational.Instrument operational.Us: although the instrument produced an error code during this incident, this is a reportable event since the pt needed to be recalled for additional sample collection, which resulted in a delay in pt diagnosis.(b)(6): this is not a reportable event per (b)(6) mandatory problem reporting requirements since there was no reportable malfunction; no serious injury or illness as a result of the device; therefore, no safety related correction action is required.

• 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: 4289317
• MDR Text Key: 5193256
• Report Number: 1222780-2014-00209
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/21/2014

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: 10/31/2014
• Initial Date FDA Received: 11/21/2014
• 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