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.
[25615145]
A customer reported in (b)(6) that their thinprep 5000 processor autoloader etched a wrong vial id onto a slide. No patient recall was required as sufficient sample was left to reprocess the vial. After 250+ attempts hologic's field service engineer was unable to reproduce the error. Hologic's field service engineer found the most likely cause of the error being caused by a barcode shining through underneath label. Instrument is operational. This is considered a reportable event since the thinprep 5000 processor autoloader did not perform as intended and this could potentially lead to ta misdiagnosis or delay in diagnosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2015-00158 |
| MDR Report Key | 5065063 |
| Date Received | 2015-09-09 |
| Date of Report | 2015-09-09 |
| Date Mfgr Received | 2015-08-12 |
| 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 | 0 |
| 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 |