MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-04 for THINPREP 5000 PROCESSOR manufactured by Hologic, Inc.
[45098008]
A customer in great britain reported two incidences where their thinprep 5000 processor with autoloader etched a wrong vial id onto a slide. The customer put the vial through again and could not reproduce the error. The instrument did not present any error to the operator. The vials were put through the machine again and the slide number was etched correctly. Therefore, there was no delay in patient diagnosis. Hologic technical service (ts) requested for a picture of the vials, but the customer wouldn't send any. Instrument is operational. Fse needs to be dispatched. (b)(4) field service engineer (fse) confirmed but unable to reproduce error. Performed all required setups per technical documentation. Performed (b)(4). 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 | 1222780-2016-00111 |
| MDR Report Key | 5632650 |
| Date Received | 2016-05-04 |
| Date of Report | 2016-05-04 |
| Date Mfgr Received | 2016-04-18 |
| Date Added to Maude | 2016-05-04 |
| 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 | 2016-05-04 |
| 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 | 2016-05-04 |