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

Model Number ASY-05528

Device Problem Facilities Issue (2935)

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

Event Date 01/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event 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
• Type of Device: AUTOMATED PROCESSOR
• Manufacturer (Section D): HOLOGIC INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 7293549
• MDR Text Key: 100837060
• Report Number: 1222780-2018-00030
• Device Sequence Number: 1
• Product Code: MKQ
• UDI-Device Identifier: 15420045504158
• UDI-Public: (01)15420045504158
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P950039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: ASY-05528
• Device Catalogue Number: ASY-05528
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2018
• Initial Date FDA Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other