MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-21 for THINPREP 2000 PROCESSOR manufactured by Hologic, Inc.
[36962971]
A customer in the us reported error codes se 45 nn on their thinprep 2000 processor. Hologic field service engineer (fse) instructed the customer to clean the cap seal ports and check the qto valve tubing. Customer called later to report multiple process cancelled evacuation failures and reported error codes se 45 and se 87. Customer cleaned the cap seal ports and rebooted the instrument and that 7 out of 20 have failed. Customer and hologic technical service agreed to put the dispatch on hold and send out a different lot of filters. Customer received replacement filters. Instrument fully operational. Jan 21, 2016: further investigation of this incident revealed patient(s) needed to be recalled for additional sample collection. Although the instrument produced an error code during this incident, this is a reportable event since the patient needed to be recalled for additional sample collection, which resulted in a delay in patient diagnosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2016-00018 |
| MDR Report Key | 5384212 |
| Date Received | 2016-01-21 |
| Date of Report | 2016-01-21 |
| Date Mfgr Received | 2015-11-20 |
| Date Added to Maude | 2016-01-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EVA MAXWELL |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THINPREP 2000 PROCESSOR |
| Generic Name | THINPREP 2000 PROCESSOR |
| Product Code | MKQ |
| Date Received | 2016-01-21 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-21 |