MAUDE Adverse Event Report: HOLOGIC INC. THINPREP 5000 PROCESSOR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Venipuncture (2129)

Event Date 01/01/2014

Event Type  No Answer Provided  

Event Description

Customer reported their thinprep 5000 was intermittently breaking slides.Customer stated that two patient needed to be called back to the doctor's office to recollect lost samples.Hologic field service engineer confirmed but was unable to reproduce the error.The field service engineer replaced the following part as a precaution; slide z cicoil, slide x cicoil, galil 1.Performed all required setups per technical documentation.Ran all non-interactive motion tests to verify instrument operation ran go no-go test to verify instrument operation processed samples to confirm operation.Instrument is operational.

• 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: 3926641
• MDR Text Key: 17617850
• Report Number: 1222780-2014-00102
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/27/2014

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: 05/27/2014
• Initial Date FDA Received: 06/17/2014
• 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