MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 5000 PROCESSOR

Device Problems Nonstandard Device (1420); Device Displays Incorrect Message (2591)

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

Event Type  No Answer Provided  

Manufacturer Narrative

Hologic field service engineer (fse) confirmed but unable to reproduce error: 6006-sh024.From customers information, 3pf the samples couldn't be recovered - patients need to be recalled.Found the following to be the most likely cause of the error: slide holder venturi.Replaced the following parts per technical documentation to resolve the error: vacuum generator slide holder.Replaced the following parts as precautionary measure: vacuum cups.Performed all required setups per technical documentation: fe transferheight, sr motor pickupslideangle, st motor pickupslideendposition.Run dooming curve to verify filter elevator transfer height per service manual processed samples to confirm operation.Instrument operational.Internal reference complaint#: (b)(4).

Event Description

The customer reported error code 6006-sh024 on the instrument.Tech support (ts) asked the customer to remove the input carousel (ic) clean the area, clean the slide gripper fingers and also the holding cups.Customer also confirmed that for one vial, the instrument used all the liquid and did not created a cell spot.Hologic field service engineer (fse) confirmed but unable to reproduce error: 6006-sh024.Ts called back the customer and it is confirmed that the customer will have to recall 3 patients because the instrument used all the liquid in the vial without creating the cell spot.Although the instrument produced an error code during this incident, this is a reportable event since the patient needed to be recalled for additional sample collection, which resulted in a delay in diagnosis.

• Brand Name: THINPREP 5000 PROCESSOR
• Type of Device: THINPREP 5000 PROCESSOR
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 5865771
• MDR Text Key: 52838033
• Report Number: 1222780-2016-00176
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2016
• 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