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

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Venipuncture (2129)

Event Date 01/01/2014

Event Type  No Answer Provided  

Event Description

Customer reported (2) instances of their thinprep 5000 instrument producing an error and stopping after sipping liquid into the filter.Customer will recall the patient for a new sample collection since the whole sample was lost.The field service engineer confirmed; but was unable to reproduce error.Replaced parted as a precautionary measure.Performed preventive maintenance and performed all required setups per technical documentation.Processed samples to confirm operation.Instrument operational.Us: this is a reportable event since the patient needed to be recalled for additional sample collection, which resulted in a delay in patient diagnosis.Great britain: this is not classified as a reportable event, per the current version of the eu meddev guidelines.There was no injury or misdiagnosis.The instrument's protection against a technical fault functioned correctly as the instrument displayed an error code to warn the user at the time and subsequently stopped.The issue was successfully resolved following field service intervention.

• Brand Name: THINPREP 5000 AUTOLOADER READY
• 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: 4101499
• MDR Text Key: 4717888
• Report Number: 1222780-2014-00143
• 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
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2014

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: 08/04/2014
• Initial Date FDA Received: 08/27/2014
• 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