MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-01 for THINPREP 5000 PROCESSOR manufactured by Hologic, Inc.
[54442117]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[54442118]
A customer in (b)(6) reported their thinprep 5000 processor with autoloader printed the wrong number on the vial. All other vials in the same processing tray were checked and the numbers were found to be correct, no extra bar codes were found. The vial number 1620013697 was reloaded as a single sample on the t5 and was reprocessed correctly. No patient recall needed. Hologic's field service engineer (fse) confirmed but unable to reproduce the error. The barcode reader with linear base scanner is the most likely cause of the barcode misread. Performed the 2d barcode reader upgrade, processed samples to confirm operation. Instrument operational.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2016-00222 |
| MDR Report Key | 5922493 |
| Date Received | 2016-09-01 |
| Date of Report | 2016-09-01 |
| Date Mfgr Received | 2016-09-01 |
| Date Added to Maude | 2016-09-01 |
| 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 | SIDRA PIRACHAL |
| 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 | 2016-09-01 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2016-09-01 |