MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 2000 PROCESSOR

Device Problem Device Displays Incorrect Message (2591)

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

Event Type  No Answer Provided  

Manufacturer Narrative

Unique identifier (udi): this unit was built before the udi was required so there isn't one available for it.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.Internal reference complaint#: (b)(4).

Event Description

Customer reported error code se 06 00 on the instrument.The customer had this issue a few times the last few days.Customer also confirmed that they had to call back one customer because all the sample was lost.The customer ran a pneumatic test and it passed.Hologic field service engineer went on site confirmed and reproduced error.Replaced the following parts, 71950-001, 70035-001 and 04958-001 to resolve the error.Performed inspection, instrument operational.Although the instrument produced an error code during this incident, this is a reportable event since a patient needed to be recalled for additional sample collection, which resulted in a delay in patient diagnosis.

• Brand Name: THINPREP 2000 PROCESSOR
• Type of Device: THINPREP 2000 PROCESSOR
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 6282358
• MDR Text Key: 65909026
• Report Number: 1222780-2017-00011
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P950039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2016

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/30/2016
• Initial Date FDA Received: 01/27/2017
• 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