MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-05-27 for CELLIENT 71663-001 manufactured by Cytyc Corp., A Family Of Hologic Companies.
[850574]
False negative on in vitro diagnostic device: customer reported no diagnostic material on cellient cell blocks. The cell block was malignant on traditional cell block and thin prep non gynecological instrument, but the cellient blocks had not diagnostic material. Customer's email stated that they had one specimen in particular that had tumor cells all over on the thin prep instrument, but nothing on the cellient. The email also stated "we are processing the cellient. The email also stated "we are processing the cellinet block first and then the thinprep using the same vial to get maximum yield on the cellient. When i pulled the vial in this case, there was a lot of material in the preservcyt vial, but instead of making a cellient we did a conventional so we would not lose the specimen we had. The conventional had groups of tumor cells.
Patient Sequence No: 1, Text Type: D, B5
[8082389]
Device being evaluated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222780-2008-00070 |
| MDR Report Key | 1053399 |
| Report Source | 07 |
| Date Received | 2008-05-27 |
| Date of Report | 2008-05-27 |
| Date of Event | 2008-04-28 |
| Date Mfgr Received | 2008-04-28 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2008-08-15 |
| 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 | 0 |
| Manufacturer Contact | RAJ KASBEKAR, MANAGER |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638858 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELLIENT |
| Generic Name | TISSUE PROCESSING EQUIPMENT |
| Product Code | KET |
| Date Received | 2008-05-27 |
| Model Number | 71663-001 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1066998 |
| Manufacturer | CYTYC CORP., A FAMILY OF HOLOGIC COMPANIES |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-05-27 |