MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-09 for THINPREP 5000 PROCESSOR manufactured by Hologic, Inc.
[25356091]
A customer reported in (b)(6) that their thinprep 5000 processor autoloader etched a wrong vial id onto a slide. The customer processed the sample a second time and it processed correctly. Hologic's technical service engineer (tse) confirmed that the chain of custody was not affected as the error was caught by the customer. Hologic's technical service engineer (tse) suggested this may be caused by the vial lift and spin causing the vial to tilt during reading or poor quality labeling. A hologic's fields service engineer (fse) was dispatched to customer site to verify set vial lift and spin set ups. Fse confirmed but was unable to reproduce the error. Fse confirmed that no patient received an incorrect diagnosis as a result of this incident. Verified and adjusted instrument vial lift and spin. Processed samples to confirm operation, instrument operational. This is considered a reportable event since the thinprep 5000 processor autoloader did not perform as intended and this could potentially lead to a misdiagnosis or delay in diagnosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2015-00159 |
| MDR Report Key | 5064519 |
| Date Received | 2015-09-09 |
| Date of Report | 2015-09-09 |
| Date Mfgr Received | 2015-09-01 |
| Date Added to Maude | 2015-09-09 |
| 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 | 3 |
| Brand Name | THINPREP 5000 PROCESSOR |
| Generic Name | THINPREP 5000 PROCESSOR |
| Product Code | MKQ |
| Date Received | 2015-09-09 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-09-09 |