MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2018-02-23 for THINPREP 5000 PROCESSOR ASY-05528 manufactured by Hologic Inc..
[100837060]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[100837061]
A customer in spain reported 5010 errors insufficient liquid in vial on their thinprep 5000 processor and two samples were lost. Patient recall was needed. A hologic field service engineer (fse) was dispatched. The fse confirmed, but was unable to reproduce error. The fse found the following to be the most likely cause of the error: need to perform tb-01234. All tests required in tb-01234: performed inspection per technical documentation. The fse ran sample processing tests to verify instrument operation. Processed samples to confirm operation, system operational.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2018-00030 |
| MDR Report Key | 7293549 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2018-02-23 |
| Date of Report | 2018-01-26 |
| Date of Event | 2018-01-26 |
| Date Mfgr Received | 2018-01-26 |
| Date Added to Maude | 2018-02-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Manufacturer Phone | 5082638884 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THINPREP 5000 PROCESSOR |
| Generic Name | AUTOMATED PROCESSOR |
| Product Code | MKQ |
| Date Received | 2018-02-23 |
| Model Number | ASY-05528 |
| Catalog Number | ASY-05528 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-02-23 |