MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-06-17 for THINPREP IMAGING SYSTEM ASY-03098 manufactured by Hologic, Inc..
[111457093]
A customer in (b)(6) reported thinprep 5000 processor with autoloader "sometimes the laser writes a wrong barcode number on slides (different from corresponding vial barcode). The issue is without errors". It is unknown if patient recall was required. The customer processed again and everything worked fine. Hologic's field service engineer (fse) fse has done a check of the instrument. He checked laser performance, vial and slide barcode readers. He has reinstalled the software 2. 1. 1. Performed slide burning test, mapping carousel using vial with labels of laboratory. Processed samples of the day. Instrument operational and released to customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2018-00070 |
| MDR Report Key | 7608578 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-06-17 |
| Date of Report | 2018-03-20 |
| Date Mfgr Received | 2018-03-20 |
| Date Added to Maude | 2018-06-17 |
| 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 IMAGING SYSTEM |
| Generic Name | AUTOMATED MICROSCOPE FOR CYTOLOGY |
| Product Code | MNM |
| Date Received | 2018-06-17 |
| Model Number | ASY-03098 |
| Operator | OTHER HEALTH CARE 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 | 2018-06-17 |