MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-18 for TTF-1 (SP141) PAB 06640613001 790-4756 manufactured by Ventana Medical Systems Inc.
[124301205]
Per package insert: intended use: anti-thyroid transcription factor-1 (sp141) rabbit monoclonal primary antibody (anti-ttf-1 (sp141) is directed against the thyroid transcription factor-1 (ttf-1) protein. This antibody exhibits a nuclear staining pattern and may be used to aid in the classification of neoplasms of the lung and thyroid. This antibody is intended for qualitative staining in sections of formalin-fixed, paraffin-embedded tissue. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. This antibody is intended for in vitro diagnostic (ivd) use. Summary and evaluation: expression of ttf-1 has now been identified in tissues and tumors previously thought to be negative with the use of newer clones and detection systems. Literature published over the past few years has demonstrated expression of ttf-1 being detected in neoplastic tissue beyond lung and thyroid. Rationale: assay is a adjunct assay used to aid in the classification of neoplasms of the lung and thyroid. Per medical opinion: case details do not provide evaluation of the h&e, a panel of stains is performed to rule in and rule out various diagnostic potentials. Assay was positive during initial run and re-run supporting no malfunction of assay. Assay ran as intended per package insert.
Patient Sequence No: 1, Text Type: N, H10
[124301206]
Patient went to the hospital. A lung tumor was expected. A lung biopsy was taken. This biopsy was positive for ttf-1 sp141 (lot# (b)(4)) which means an adenocarcinoma of the lung. This sample was very positive, lung control tissue on the same slide stained appropriate as well. This patient was sent to another hospital since tumor outgrowth in the "torax" was diagnosed. A surgery was performed based on the ttf-1 results. Just as control, a ttf-1 staining has been performed after the surgery in this hospital where the surgery has been performed (dako omnis staining platform, ttf-1 dako antibody): staining negative for ttf-1. This means that it could not be an adenocarcinoma of the lung and that the wrong treatment might have been performed. Additional stainings have been performed. This tumor stains positive for b-cell lymphoma on the dako omnis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028492-2018-00012 |
| MDR Report Key | 7982260 |
| Date Received | 2018-10-18 |
| Date of Report | 2018-10-18 |
| Date of Event | 2018-08-15 |
| Date Mfgr Received | 2018-09-25 |
| Date Added to Maude | 2018-10-18 |
| 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 | NA TIM GIBLIN |
| Manufacturer Street | 1910 EAST INNOVATION PARK DR NA |
| Manufacturer City | TUCSON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 5208777035 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TTF-1 (SP141) PAB |
| Generic Name | TTF1 |
| Product Code | NJT |
| Date Received | 2018-10-18 |
| Model Number | 06640613001 |
| Catalog Number | 790-4756 |
| Lot Number | E03354 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTANA MEDICAL SYSTEMS INC |
| Manufacturer Address | 1910 E INNOVATION PARK DR NA TUCSON AZ 857551962 US 857551962 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-18 |