MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-11 for THINPREP 5000 PROCESSOR manufactured by Hologic Inc..
[24698812]
A customer reported in (b)(6) that their thinprep 5000 processor autoloader etched a wrong id onto a slide. The customer processed the sample a second time and it processed correctly. No pt recall was required as a result of the error and no further instances of misprints were reported. Hologic technical service asked the customer to keep the vial and the slide for investigation purposes. Hologic's field service engineer confirmed and reproduced the error. Found the most likely cause of the error being a poorly printed additional barcode label applied to the vial by the general practitioner being read instead of a laboratory applied label. Instrument is operational. This is considered a reportable event since the thinprep 5000 processor did not perform as intended and this could potentially lead to a misdiagnosis or delay in diagnosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2015-00142 |
| MDR Report Key | 5000664 |
| Date Received | 2015-08-11 |
| Date of Report | 2015-08-11 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2015-08-03 |
| Date Added to Maude | 2015-08-13 |
| 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 | 2015-08-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC INC. |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-11 |