MAUDE Adverse Event Report: HOLOGIC IN THINPREP 2000 PROCESSOR

Device Problems Suction Problem (2170); Device Displays Incorrect Message (2591)

Patient Problem Venipuncture (2129)

Event Date 01/01/2014

Event Type  Other  

Event Description

Customer reported (2) instances of their thinprep 2000 processor instrument producing an error (45).In both cases all of the specimen was sucked up into the system forcing pt to go back to the doctor to acquire additional sampling.The field service engineer confirmed; but was unable to reproduce error.Performed all required setups per technical documentation.Ran pneumatic test and blank sample.Instrument operational.

• Brand Name: THINPREP 2000 PROCESSOR
• Type of Device: THINPREP 2000 PROCESSOR
• Manufacturer (Section D): HOLOGIC IN; marlborough MA
• Manufacturer Contact: eva maxwell ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 3897638
• MDR Text Key: 4423767
• Report Number: 1222780-2014-00090
• 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: 05/15/2014

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: 05/15/2014
• Initial Date FDA Received: 06/10/2014
• 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