MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-24 for THINPREP 5000 PROCESSOR manufactured by Hologic, Inc.
[46277949]
A customer in (b)(6) reported an incident which occurred on (b)(6) 2016 where their thinprep 5000 processor with autoloader produced a slide incorrectly etched with a mismatched number; without producing an error code. The issue was discovered by the customer's qc procedure. Hologic field service engineer (fse) confirmed that the sample was reprocessed and read correctly and has not caused a patient recall or delay in diagnosis. Hologic field service engineer (fse) confirmed but unable to reproduce error. Checked all required setups per technical documentation. Performed tsb 00882. Performed all required setups per technical documentation. Processed samples to confirm operation. Instrument operational. Although no patients needed to be recalled as a result of this incident, this is a reportable event since the instrument did not perform as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2016-00134 |
| MDR Report Key | 5676207 |
| Date Received | 2016-05-24 |
| Date of Report | 2016-05-24 |
| Date Mfgr Received | 2016-04-27 |
| Date Added to Maude | 2016-05-24 |
| 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 | 0 |
| Brand Name | THINPREP 5000 PROCESSOR |
| Generic Name | THINPREP 5000 PROCESSOR |
| Product Code | MKQ |
| Date Received | 2016-05-24 |
| 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 | 2016-05-24 |