MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 2000 PROCESSOR

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  No Answer Provided  

Event Description

A customer in belgium reported an instance of their thinprep 5000 processor producing error code se 90 00.Error occurred 2 times.Hologic's technical service requested customer to run a pneumatic test; test was successful and was able to process two urine samples while on the phone without any issues.Customer requested hologic field service engineer (fse) to be dispatched to investigate.Instrument operational.Fse was dispatched.Customer called back and informed (b)(4) that instrument is now down.Patient sample was lost and will have to recall a patient for additional sample collection.Fse confirmed and reproduced error.Replaced the following parts per technical documentation to resolve the error.Qto valve.Ran pneumatic test and blank samples.Instrument operational.Although the instrument produced an error code during this incident, this is a reportable event since a patient needed to be recalled for additional sample collection, which resulted in a delay in patient diagnosis.

• Brand Name: THINPREP 2000 PROCESSOR
• Type of Device: THINPREP 2000 PROCESSOR
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 5632643
• MDR Text Key: 45098524
• Report Number: 1222780-2016-00109
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2016

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: 04/13/2016
• Initial Date FDA Received: 05/04/2016
• 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