MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC TTF-1 (SP141) PAB; TTF1

Model Number 06640613001

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Cancer (3262)

Event Date 08/15/2018

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: TTF-1 (SP141) PAB
• Type of Device: TTF1
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; tucson AZ 85755 1962
• Manufacturer Contact: tim giblin ; 1910 east innovation park dr; na; tucson, AZ 85755 ; 5208777035
• MDR Report Key: 7982260
• MDR Text Key: 124301205
• Report Number: 2028492-2018-00012
• Device Sequence Number: 1
• Product Code: NJT
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: CLASS1EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 06640613001
• Device Catalogue Number: 790-4756
• Device Lot Number: E03354
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other