MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-07-27 for BOND READY TO USE TTF-1 PRIMARY ANTIBODY PA0364 manufactured by Leica Biosystems Newcastle Ltd..
[1570344]
The customer reported to leica microsystem false positive staining on paraffin sections of thymoma with ttf-1 (thyroid transcription factor-1) antibody. Lung and thyroid tumors are known to be positive with tff-1 antibodies but staining on thymomas has not previously been described. No misdiagnosis occurred in this case.
Patient Sequence No: 1, Text Type: D, B5
[8679077]
Leica's investigation of this complaint has determined that the staining in thymoma is correct and not a false positive. However, the instructions for use only indicate that thyroid and lung tumors should be positive. Based on our current investigations, the instructions for use for this product will be updated to reflect the staining of other tissues. Customers will be informed of this change with a field correction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004859032-2010-00001 |
| MDR Report Key | 1786222 |
| Report Source | 07 |
| Date Received | 2010-07-27 |
| Date of Report | 2010-06-29 |
| Date of Event | 2010-06-29 |
| Date Mfgr Received | 2010-06-29 |
| Device Manufacturer Date | 2009-08-01 |
| Date Added to Maude | 2011-02-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | BALLIOL BUSINESS PARK BENTON LANE |
| Manufacturer City | NEWCASTLE UPON TYNE NE1 8EW |
| Manufacturer Country | UK |
| Manufacturer Postal | NE1 8EW |
| Manufacturer Phone | 912150567 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOND READY TO USE TTF-1 PRIMARY ANTIBODY |
| Generic Name | IMMUNOHISTOCHEMISTRY REAGENT |
| Product Code | NJT |
| Date Received | 2010-07-27 |
| Model Number | TTF-1 |
| Catalog Number | PA0364 |
| Lot Number | 08679 |
| Device Expiration Date | 2012-07-29 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NEWCASTLE LTD. |
| Manufacturer Address | BALLIOL BUSINESS PARK BENTON LANE NEWCASTLE UPON TYNE NE128EW UK NE12 8EW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-27 |