MAUDE Adverse Event Report: HOLOGIC INC. THINPREP 5000 PROCESSOR; AUTOMATED PROCESSOR

Model Number	ASY-05528
Medical Device Problem Code	Facilities Issue (2935)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
A customer in spain reported 5010 errors insufficient liquid in vial on their thinprep 5000 processor and two samples were lost.Patient recall was needed.A hologic field service engineer (fse) was dispatched.The fse confirmed, but was unable to reproduce error.The fse found the following to be the most likely cause of the error: need to perform tb-01234.All tests required in tb-01234: performed inspection per technical documentation.The fse ran sample processing tests to verify instrument operation.Processed samples to confirm operation, system operational.

• Brand Name: THINPREP 5000 PROCESSOR
• Common Device Name: AUTOMATED PROCESSOR
• Manufacturer (Section D): HOLOGIC INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 7293549
• Report Number: 1222780-2018-00030
• Device Sequence Number: 19126869
• Product Code: MKQ
• UDI-Device Identifier: 15420045504158
• UDI-Public: (01)15420045504158
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P950039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2018

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
• Operator of Device: Health Professional
• Device Model Number: ASY-05528
• Device Catalogue Number: ASY-05528
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other