MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-04 for THINPREP 2000 PROCESSOR manufactured by Hologic, Inc.
[45098524]
A customer in belgium reported an instance of their thinprep 5000 processor producing error code se 90 00. Error occurred 2 times. Hologic's technical service requested customer to run a pneumatic test; test was successful and was able to process two urine samples while on the phone without any issues. Customer requested hologic field service engineer (fse) to be dispatched to investigate. Instrument operational. Fse was dispatched. Customer called back and informed (b)(4) that instrument is now down. Patient sample was lost and will have to recall a patient for additional sample collection. Fse confirmed and reproduced error. Replaced the following parts per technical documentation to resolve the error. Qto valve. Ran pneumatic test and blank samples. Instrument operational. Although the instrument produced an error code during this incident, this is a reportable event since a patient needed to be recalled for additional sample collection, which resulted in a delay in patient diagnosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2016-00109 |
| MDR Report Key | 5632643 |
| Date Received | 2016-05-04 |
| Date of Report | 2016-05-03 |
| Date Mfgr Received | 2016-04-13 |
| 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 | MS SIDRA PIRACHA |
| 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 2000 PROCESSOR |
| Generic Name | THINPREP 2000 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 |