MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-28 for THINPREP 5000 PROCESSOR manufactured by Hologic, Inc.
[45097910]
A customer in (b)(6) reported their thinprep 5000 processor etched a wrong vial id onto 2 slides. Instrument operational, (b)(4) field service engineer (fse) dispatched. The instrument processed normally without any error presented to the operator. Fse noted 1d label on the vial, 2d label on the slide. The customer confirmed no patients needed to be recalled as a result of this incident as they were able to reprocess the slide with the correct label printed on the slide. Fse performed preventative maintenance per technical documentation. 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 | 1222780-2016-00105 |
| MDR Report Key | 5615762 |
| Date Received | 2016-04-28 |
| Date of Report | 2016-04-28 |
| Date Mfgr Received | 2016-03-29 |
| Date Added to Maude | 2016-04-28 |
| 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 PIRACHA |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638884 |
| 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 | 2016-04-28 |
| 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 | 2016-04-28 |