MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 5000 PROCESSOR

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device history record (dhr) review was conducted for the reported identification number.The serial number was released meeting all qa specifications.(b)(4).

Event Description

Customer reported an anomaly with a sample preparation.A cervical sample processed on the thinprep 5000 processor, which was then classified as negative.The sample was then re-processed on the thinprep 2000 processor, as part of the laboratory stain check procedure.On checking this sample under the microscope it was noted that the sample contained high grade dyskaryosis.On re-screening the original slide this was found to be negative, which was confirmed by two checkers and a consultant.To check that the thinprep 2000 processor stain check sample was made from the correct vial the customer made a third slide on the thinprep 2000 processor which again had similar high grade dyskaryotic cells present as those seen in the stain check slide.The customer re-issued the report to the sample taker as moderate dyskaryosis.The lab is confident the vials were not mixed up as they do not keep patient samples in the room with the thinprep 2000 processor.They only keep the new vials and the samples they are prepping.Old samples are kept in another room down the corridor.The patient went for a colposcopy which revealed a the section shows ectocervical mucosa and freelying fragments of benign endocervical epithelium.The transformation zone is not included.No cin seen.The colposcopists opinion is listed on cyres colposcopy as "other".So the biopsy was negative but the colposcopists opinion on the system is not negative' or normal'.The system was checked and no issues were found, system operational.Based on the inconclusive findings this event is being reported.

• 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 ; 5082633884
• MDR Report Key: 6567362
• MDR Text Key: 75173728
• Report Number: 1222780-2017-00124
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: 950039/S26
• 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: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/15/2017
• 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): Required Intervention