MAUDE Adverse Event Report: HOLOGIC INC. THINPREP 5000 PROCESSOR

Device Problems Display Difficult to Read (1181); Device Markings/Labelling Problem (2911)

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

Event Date 01/01/2015

Event Type  No Answer Provided  

Event Description

A customer reported in (b)(6) that their thinprep 5000 processor autoloader etched a wrong id onto a slide.The customer processed the sample a second time and it processed correctly.No pt recall was required as a result of the error and no further instances of misprints were reported.Hologic technical service asked the customer to keep the vial and the slide for investigation purposes.Hologic's field service engineer confirmed and reproduced the error.Found the most likely cause of the error being a poorly printed additional barcode label applied to the vial by the general practitioner being read instead of a laboratory applied label.Instrument is operational.This is considered a reportable event since the thinprep 5000 processor did not perform as intended and this could potentially lead to a misdiagnosis or delay in diagnosis.

• Brand Name: THINPREP 5000 PROCESSOR
• Type of Device: THINPREP 5000 PROCESSOR
• Manufacturer (Section D): HOLOGIC INC.; marlborough MA
• Manufacturer Contact: eva maxwell ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 5000664
• MDR Text Key: 24698812
• Report Number: 1222780-2015-00142
• 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
• Source Type: unknown
• Reporter Occupation: Other
• Report Date: 08/11/2015

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: Not provided
• Initial Date FDA Received: 08/11/2015
• 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