MAUDE Adverse Event Report: HOLOGIC, INC. THINPREP 2000 PROCESSOR

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 03/01/2014

Event Type  No Answer Provided  

Event Description

Possible false negative incidents have occurred, however, no misdiagnosis has occurred.The chief pathologist from the public health laboratory services in (b)(6) reported that the first sputum slide processed with the thin prep 2000 processor was negative with low cellularity.The pt has recent history of abnormality, so she asked the lab technician to prepare the second slide from the same vial without any treatment and she found more than 5 clusters of abnormal cells with confirmed diagnosis of adenocarcinoma (non-gyn cytology).After 2 weeks, she found another case of sputum with similar discrepancy.However for this case, the first slide has satisfactory cellularity.She asked for the preparation of second slide from the same vial without treatment because the pt again has recent history of abnormality.

• Brand Name: THINPREP 2000 PROCESSOR
• Type of Device: THINPREP 2000 PROCESSOR
• Manufacturer (Section D): HOLOGIC, INC.; marlborough MA
• Manufacturer Contact: eva maxwell ; 250 campus drive; marlborough, MA 01752 ; 5082638922
• MDR Report Key: 3805871
• MDR Text Key: 4365706
• Report Number: 1222780-2014-00075
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 04/01/2014

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
• Initial Date Manufacturer Received: 04/01/2014
• Initial Date FDA Received: 04/30/2014
• 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