MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 5000 PROCESSOR

Device Problems Human Factors Issue (2948); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  No Answer Provided  

Event Description

A customer in (b)(6) first reported an incident in (b)(6) 2016 to (b)(6) field service engineer (fse) where their thinprep 5000 processor with autoloader etched a slide with a wrong id number.*due to a misunderstanding of the event between the customer and (b)(6) field service engineer (fse), initially the incident was not considered a reportable event by the fse.The fse understood the event as the instrument could not read a slide id of one particular slide.The customer actually reported that the autoloader etched a slide with a wrong id number.The misunderstanding was discovered on (b)(6) when the customer reviewed the field service report from the fse visit in (b)(6) and noticed the miscommunication of the event, then notified hologic customer service and this event was elevated as a pae.Hologic's field service engineer (fse) confirmed with the customer that the patients sample was found and reprocessed.The barcode produced was correct and matched the vial id upon processing the sample the second time.Therefore, no patient recall was necessary.In addition, it was confirmed by the fse that no error code was presented to the operator.Fse confirmed but unable to reproduce the error, one slide printed with wrong id.Fse found the following to be the most likely cause of the error: vial barcode reader.Performed tsb 00882 to resolve the problem (see sr #(b)(4)).Ran go no-go test to verify instrument operation.Processed samples to confirm operation.Instrument operational.Although no patients needed to be recalled as a result of this incident this is a reportable event since the instrument did not perform as intended.

• Brand Name: THINPREP 5000 PROCESSOR
• Type of Device: THINPREP 5000 PROCESSOR
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: eva maxwell ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 5747724
• MDR Text Key: 49300830
• Report Number: 1222780-2016-00163
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• 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: 06/02/2016
• 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