MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 5000 PROCESSOR

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

A customer in (b)(6) reported their thinprep 5000 processor with autoloader etched a wrong vial id onto a slide.The slides were processed on (b)(6) 2016.Based on the pictures that were obtained the quality of these labels/barcodes have deteriorated compared to last time.It was noted that the barcode in question is very poor in the fact that it has ink bleed and bare patches.The instrument gave no error code for slide id (b)(6).It was confirmed that all faulty slide id's were found and reprocessed, and there was no patient recall or delay in diagnosis as a result.Customer has two different barcodes on vial, advised customer to strike through redundant barcode with black marker.Hologic field service engineer confirmed and reproduced error.Performed preventative maintenance per technical documentation.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: 5536228
• MDR Text Key: 42873388
• Report Number: 1222780-2016-00073
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• 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: 02/29/2016
• 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