MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-24 for THINPREP 5000 PROCESSOR manufactured by Hologic, Inc.
[32100900]
A customer in (b)(6) reported their thinprep 5000 processor with autoloader etched a wrong vial id onto a slide. The error was caught by the customer at the time and no patients were affected. Hologic's field service engineer (fse) was unable to confirm the error. This is considered a reportable event since the thinprep 5000 processor did not perform as intended.
Patient Sequence No: 1, Text Type: D, B5
[37573781]
After reassessing this incident it has been determined that the customer was using an unsupported label barcode symbology; therefore this is not a reportable event in the us as it was previously reported (1222780-2015-00214). As per the current operator manual (man-01783-001 rev 008) the only supported symbologies are code 128, interleaved 2 of 5, code 39 and code 93; the customer was using codabar symbology.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222780-2015-00215 |
| MDR Report Key | 5247502 |
| Date Received | 2015-11-24 |
| Date of Report | 2015-11-23 |
| Date Mfgr Received | 2015-11-06 |
| Date Added to Maude | 2015-11-24 |
| 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 | 2015-11-24 |
| Device Availability | N |
| Device Age | DA |
| 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 | 2015-11-24 |